ID

38904

Beskrivning

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to check the subject's eligibility and should be filled in at Visit 1 (Screening).

Länk

https://clinicaltrials.gov/ct2/show/NCT00992160

Nyckelord

Versioner (3)
  1. 2019-03-01 2019-03-01 -
  2. 2019-11-12 2019-11-12 -
  3. 2019-11-12 2019-11-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

12 november 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Engelsk

Eligibility Criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Beskrivning

Study site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Beskrivning

Subject No.

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Eligibility Criteria
Beskrivning

Eligibility Criteria

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beskrivning

If No, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
The subject must be able to read and understand the informed consent form and provide written informed consent, indicating the subject's understanding of the purpose of the study and willingness to comply with all study procedures described in the protocol, including all sleeplaboratory restrictions and procedures.
Beskrivning

Able to Read/Understand/Provide Informed Consent and Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0162340
UMLS CUI [3]
C0021430
UMLS CUI [4]
C0525058
Male and female subjects 18 through 64 years of age (inclusive).
Beskrivning

Gender and Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Diagnosis of Primary Insomnia, based on Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) criteria 307.42
Beskrivning

• A complaint of difficulty initiating and maintaining sleep or of nonrestorative sleep three or more times per week, for at least the 3 months preceding screening . • The sleep disturbance causes clinically significant distress or impairment in social, occupational, or other impo1tant areas of functioning. • The disturbance in sleep does not occur exclusively during the course of another sleep disorder or occur exclusively during the course of another mental disorder. • Lastly, the disturbance is not due to the direct physiological effects of a substance or general medical condition, such as lung disease, cerebrovascular disease, systemic infectious disease, cancer, chronic pain conditions (e.g. arthritis), endocrine conditions, and degenerative neurological disorders.

Datatyp

boolean

Alias
UMLS CUI [1]
C0033139
UMLS CUI [2]
C0220952
The subject's self-reported sleep history includes at least three months of a usual (i.e. > 3 nights per week) TST of less than 6.0 hours, a sleep onset latency (SOL) of at least 30 minutes and WASO >= 60 minutes.
Beskrivning

Self-reported history of sleep problems, by total sleep time, sleep onset latency, and wake after sleep onset

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2700446
UMLS CUI [1,2]
C3539544
UMLS CUI [2]
C4722414
UMLS CUI [3]
C4505222
UMLS CUI [4]
C4744894
Time in bed between 6.5 and 8.5 hours for least 5 nights per week over the preceding 3 months.
Beskrivning

Time spent in bed

Datatyp

boolean

Alias
UMLS CUI [1]
C2135946
Bed time between 21.00 and 24.00 hours that does not vary by more than +/- 2 hours over the preceding 3 months. Bedtime (lights out) will be confirmed by a one-week diary completed before the first PSG screening session (Visits 2/3).
Beskrivning

Constant Bedtime, confirmed by diary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4053890
UMLS CUI [1,2]
C1948059
UMLS CUI [2]
C3890583
The sleep variables obtained from the two screening PSG sessions (with single-blinded placebo administration at each night) must fall within the following ranges: - TST between 240 and 420 minutes inclusive on both nights - Mean LPS of 20 minutes or more, and LPS not < 15 minutes on either night - Mean WASO of 60 minutes or more, and WASO not < 45 minutes on either night
Beskrivning

Polysomnography results: Total sleep time, sleep latency, wake after sleep onset

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162701
UMLS CUI [1,2]
C0456984
UMLS CUI [2]
C4722414
UMLS CUI [3]
C0430629
UMLS CUI [4]
C4744894
A female subject is eligible to participate if she is of: - Non-childbearing potential - Child-bearing potential and agrees to use one of the contraception methods listed in Section 4.5 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. - Female subjects must agree to use contraception until 3 days post-last dose.
Beskrivning

Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
The subject is in good health as determined by medical and psychiatric history, physical examination, ECG, and serum chemistry, hematology, serology, and urinalysis results.
Beskrivning

Health Status by medical and psychiatric history, physical examination, ECG, and serum chemistry, hematology, serology, and urinalysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0018759
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0748059
UMLS CUI [4]
C0031809
UMLS CUI [5]
C1623258
UMLS CUI [6]
C1883010
UMLS CUI [7]
C0474523
UMLS CUI [8]
C0036743
UMLS CUI [9]
C0042014
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder.
Beskrivning

Symptoms of sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0851578
UMLS CUI [1,3]
C0033139
UMLS CUI [1,4]
C0332300
UMLS CUI [2]
C0037315
UMLS CUI [3]
C0035258
UMLS CUI [4]
C0813142
Any clinically significant Axis I psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
Beskrivning

Significant Psychiatric Axis I except primary insomnia (by DSM-IV)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C0033139
UMLS CUI [1,5]
C0332300
UMLS CUI [2]
C0220952
Subject has a recent history (12 months) of mood or other mental disorders that the investigator regards as accounting for the insomnia.
Beskrivning

Recent mood or mental disorder causing insomnia by investigator judgement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525045
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0917801
UMLS CUI [1,5]
C0022423
UMLS CUI [1,6]
C0008961
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0004936
UMLS CUI [2,3]
C0332185
UMLS CUI [2,4]
C0566251
UMLS CUI [2,5]
C0917801
UMLS CUI [2,6]
C0022423
UMLS CUI [2,7]
C0008961
Subject has a Beck Depression Inventory (Version II) [Beck, 1996] total score of 29 or greater at the Screening Visit (Visit 1) or at Visit 4 (if 2 weeks have elapsed between screening visit and randomization).
Beskrivning

Patients scoring 17 to 28 must be confirmed to not have major depressive illness to be eligible.

Datatyp

boolean

Alias
UMLS CUI [1]
C2960571
History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence (with the exception of tobacco use) within the past 12 months as defined by DSM-IV-TR.
Beskrivning

Recent Alcohol, Narcotic, Benzodiazepine or other Substance Abuse except tobacco use (by DSM-IV criteria)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0085762
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0524661
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0338768
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C0205394
UMLS CUI [4,3]
C0038580
UMLS CUI [4,4]
C1705847
UMLS CUI [4,5]
C0543414
UMLS CUI [5]
C0220952
Positive urine drug screen ( i.e. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) at Screening Visit (Visit 1). A repeat test will not be allowed if the result is positive.
Beskrivning

Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)

Datatyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0002667
UMLS CUI [3]
C0004745
UMLS CUI [4]
C0005064
UMLS CUI [5]
C0006864
UMLS CUI [6]
C0009170
UMLS CUI [7]
C0376196
Positive alcohol breath test at Screening Visit (Visit l), i.e. alcohol level greater than 0.015% after subject being told that they must not drink for 8 hours preceding the Screening Visit (Visit I). A repeat test will not be allowed if the result is positive.
Beskrivning

Positive Alcohol Breath Test

Datatyp

boolean

Alias
UMLS CUI [1]
C1112499
Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (except febrile seizure).
Beskrivning

History of neurological disorder (incl. dementia, cognitive disorder, significant head injury) or seizures (except febrile seizures)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027765
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0497327
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0009241
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0018674
UMLS CUI [4,3]
C1546944
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0036572
UMLS CUI [5,3]
C1705847
UMLS CUI [5,4]
C0009952
Subjects with an unstable medical disorder or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of vestipitant, may pose a safety concern, or interfere with accurate assessment of efficacy or safety.
Beskrivning

Unstable Medical Disorder or disorder interfering pharmacodynamics/pharmacokinetics of vestipitant, safety or evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2607417
UMLS CUI [2,4]
C0243145
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2607417
UMLS CUI [3,4]
C0031328
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0036043
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0220825
Subjects have any screening electrocardiography (ECG) parameter outside of the Sponsor-specified ranges as determined by a central ECG reader (See Appendix 2: ECG Parameters); the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the first screening PSG session (Visit 2).
Beskrivning

ECG Abnormalities by Sponsor criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C2347796
Subjects have any ECG finding that in the Investigator's judgement is considered to be clinically significant and not resolved by the first day of screening PSG session (Visit 2) (even if not outside of Sponsor-specified ranges in Appendix 2: ECG Parameters).
Beskrivning

ECG Abnormalities by Investigator Judgement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C0008961
Known seropositivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
Beskrivning

HIV, Hepatitis B or Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
Women having a positive serum HCG pregnancy test at the Screening Visit (Visit 1), a positive urine pregnancy dipstick during the screening PSG session (Visit 2) or at Visit 4 (Randomization), or who are lactating or planning to become pregnant within 14 weeks following the Screening Visit (Visit 1).
Beskrivning

Positive serum/urine pregnancy test, lactating or planning to become pregnant

Datatyp

boolean

Alias
UMLS CUI [1]
C0430059
UMLS CUI [2]
C0430063
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0006147
Subjects have any screening laboratory value outside of the Sponsorspecified ranges at the Screening Visit (Visit 1) (See Appendix 3: Laboratory Parameters). Testing may be repeated once to see if value returns to within range but any such laboratory abnormality must be resolved by the screening PSG session (Visit 2).
Beskrivning

Laboratory Tests Abnormal by Sponsor criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C2347796
Subjects have any laboratory abnormality that in the Investigator's judgement is considered to be clinically significant and not resolved by the first day of the screening PSG session (Visit 2) (even if not outside of Sponsor-specified ranges in Appendix 3: Laboratory Parameters).
Beskrivning

Laboratory Results Abnormal by Investigator Judgement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C0008961
Subjects who are not euthyroid based on laboratory tests at the screening visit. Subjects maintained on thyroid medication must be euthyroid for a period of at least 6 months prior to the Screening Visit (Visit 1), with no dose changes.
Beskrivning

Abnormal thyroid function

Datatyp

boolean

Alias
UMLS CUI [1]
C0476414
Body mass index of 34 or more at the Screening Visit (Visit 1).
Beskrivning

BMI

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Apnea-hypopnea index of 10 or more on Night 1 screening PSG (Visit 2). Subjects failing Night I screening PSG should not be screened on Night 2 (Visit 3).
Beskrivning

Apnea-hypopnea Index

Datatyp

boolean

Alias
UMLS CUI [1]
C2111846
Periodic limb movements with arousal of 10 or more/hour of sleep on Night 1 screening PSG (Visit 2). Subjects failing Night 1 screening PSG should not be screened on Night 2 (Visit 3).
Beskrivning

Periodic Limb Movements with Arousal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1561887
UMLS CUI [1,2]
C0003808
Nightshift or rotating shift-work within 1 month preceding the Screening Visit (Visit 1) or during the study period.
Beskrivning

Recent or current nightshift or rotating shifts

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C4505094
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C4505093
UMLS CUI [3,1]
C0521116
UMLS CUI [3,2]
C4505094
UMLS CUI [4,1]
C0521116
UMLS CUI [4,2]
C4505093
Planned travel across more than 3 time zones during the study or in the 2 weeks preceding the Screening Visit (Visit 1).
Beskrivning

Recent or planned travel across time zones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C2825194
UMLS CUI [1,3]
C0040802
UMLS CUI [2,1]
C0040802
UMLS CUI [2,2]
C2825194
UMLS CUI [2,3]
C0332185
Regular napping, i.e. more than 2 naps per week.
Beskrivning

Regular Napping

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870935
UMLS CUI [1,2]
C0205272
Consumption of beverages or foods containing a total of 300 mg or more per day on average of caffeine or other xanthines ( e.g. coffee, cola, tea, chocolate) over the one month preceding the Screening Visit (Visit 1)
Beskrivning

Note: 360 mL soda = ~50mg, 210 mL coffee or 60 mL espresso = ~100 mg, 210mL tea = ~75mg caffeine.

Datatyp

boolean

Alias
UMLS CUI [1]
C0948365
UMLS CUI [2,1]
C0043314
UMLS CUI [2,2]
C1512806
Smoking more than 1 pack of cigarettes (20) per day on average over the one month preceding the Screening Visit (Visit 1), or routinely a smoker during the night.
Beskrivning

Smoking Status or Nighttime smoking

Datatyp

boolean

Alias
UMLS CUI [1]
C1519386
UMLS CUI [2,1]
C0037369
UMLS CUI [2,2]
C0240526
Typical consumption of more than 14 alcoholic units in any week, or more than 3 alcoholic units in any single day, over the one month preceding the Screening Visit (Visit 1)
Beskrivning

Note: 1 unit= 240mL beer, 90mL wine, or 30mL hard liquor.

Datatyp

boolean

Alias
UMLS CUI [1]
C0001948
Use of any psychotropic medications, such as benzodiazepines and other anxiolytics, barbiturates, and narcotics, or other medications, including over-the-counter (OTC) products, that may affect sleep/wake function within 1 week or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1) or need to use any of these medications at any time during the study.
Beskrivning

Use of Psychotropic Medications, e.g. benzodiazepines, anxiolytics, barbiturates, narcotics, or others incl. OTC drugs affecting sleep/wake function

Datatyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0005064
UMLS CUI [3]
C0040616
UMLS CUI [4]
C0004745
UMLS CUI [5]
C0027415
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0205394
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C4062291
UMLS CUI [7,1]
C2709201
UMLS CUI [7,2]
C0013227
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C4062291
Cognitive Behavioral Therapy started within 1 month prior to the screening vis it ( i.e. within one month of Visit 1).
Beskrivning

Recently started Cognitive Behavioral Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0009244
Has received chronic therapy with systemic corticosteroids within 12 months prior to the Screening Visit (Visit 1). Asthmatic subjects using an inhaled corticosteroid as part of their regular maintenance therapy are eligible provided their asthma is under control (especially as night).
Beskrivning

Chronic Systemic Corticosteroids, except inhaled corticosteroids in controlled asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C4053960
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2911690
UMLS CUI [2,3]
C0004096
UMLS CUI [2,4]
C2065041
Any history of depot neuroleptic use.
Beskrivning

Depot Neuroleptic Use

Datatyp

boolean

Alias
UMLS CUI [1]
C2585377
All other drugs metabolized via the P450 3A4 pathway and CYP3A4 inducers/inhibitors, including over-the-counter (OTC) and herbal products, must be discontinued from screening and are not allowed for the duration of the study (See Appendix 4).
Beskrivning

Drugs (incl. OTC drugs and herbal products) metabolized by CYP3A4 or CYP3A4 inducers/inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1142644
UMLS CUI [1,3]
C1524026
UMLS CUI [2,1]
C1142644
UMLS CUI [2,2]
C1524026
UMLS CUI [3,1]
C0025125
UMLS CUI [3,2]
C1142644
UMLS CUI [3,3]
C1524026
UMLS CUI [4]
C3830624
UMLS CUI [5]
C3830625
Subjects who have a history of allergic reaction to, or significant adverse effects from vestipitant or closely related compounds.
Beskrivning

Allergic Reaction or significant Adverse Effects to Vestipant or similar compounds

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C2607417
UMLS CUI [2,1]
C0750502
UMLS CUI [2,2]
C0559546
UMLS CUI [2,3]
C2607417
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C2607417
UMLS CUI [3,3]
C2348205
UMLS CUI [4,1]
C0750502
UMLS CUI [4,2]
C0559546
UMLS CUI [4,3]
C2607417
UMLS CUI [4,4]
C2348205
Subjects who have had hypersensitivity or intolerance to NK1 antagonists.
Beskrivning

Hypersensitivity to NK1 Antagonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3543440
Subjects who are currently participating in a clinical trial in which the subject is or will be exposed to an investigational or noninvestigational drug or device, or have done so within the preceding 3 months.
Beskrivning

Drug or Device Trial Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0025080
Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
Beskrivning

Noncompliance expected in investigator's opinion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376405
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0022423
UMLS CUI [1,4]
C0008961
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Similar models

Eligibility Criteria

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Criteria
C1516637 (UMLS CUI-1)
Eligibility Criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Able to Read/Understand/Provide Informed Consent and Protocol Compliance
Item
The subject must be able to read and understand the informed consent form and provide written informed consent, indicating the subject's understanding of the purpose of the study and willingness to comply with all study procedures described in the protocol, including all sleeplaboratory restrictions and procedures.
boolean
C0586740 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
C0525058 (UMLS CUI [4])
Gender and Age
Item
Male and female subjects 18 through 64 years of age (inclusive).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Primary Insomnia diagnosis by DSM-IV
Item
Diagnosis of Primary Insomnia, based on Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) criteria 307.42
boolean
C0033139 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
Self-reported history of sleep problems, by total sleep time, sleep onset latency, and wake after sleep onset
Item
The subject's self-reported sleep history includes at least three months of a usual (i.e. > 3 nights per week) TST of less than 6.0 hours, a sleep onset latency (SOL) of at least 30 minutes and WASO >= 60 minutes.
boolean
C2700446 (UMLS CUI [1,1])
C3539544 (UMLS CUI [1,2])
C4722414 (UMLS CUI [2])
C4505222 (UMLS CUI [3])
C4744894 (UMLS CUI [4])
Time spent in bed
Item
Time in bed between 6.5 and 8.5 hours for least 5 nights per week over the preceding 3 months.
boolean
C2135946 (UMLS CUI [1])
Constant Bedtime, confirmed by diary
Item
Bed time between 21.00 and 24.00 hours that does not vary by more than +/- 2 hours over the preceding 3 months. Bedtime (lights out) will be confirmed by a one-week diary completed before the first PSG screening session (Visits 2/3).
boolean
C4053890 (UMLS CUI [1,1])
C1948059 (UMLS CUI [1,2])
C3890583 (UMLS CUI [2])
Polysomnography results: Total sleep time, sleep latency, wake after sleep onset
Item
The sleep variables obtained from the two screening PSG sessions (with single-blinded placebo administration at each night) must fall within the following ranges: - TST between 240 and 420 minutes inclusive on both nights - Mean LPS of 20 minutes or more, and LPS not < 15 minutes on either night - Mean WASO of 60 minutes or more, and WASO not < 45 minutes on either night
boolean
C0162701 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C4722414 (UMLS CUI [2])
C0430629 (UMLS CUI [3])
C4744894 (UMLS CUI [4])
Child Bearing Potential and Contraception
Item
A female subject is eligible to participate if she is of: - Non-childbearing potential - Child-bearing potential and agrees to use one of the contraception methods listed in Section 4.5 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. - Female subjects must agree to use contraception until 3 days post-last dose.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Health Status by medical and psychiatric history, physical examination, ECG, and serum chemistry, hematology, serology, and urinalysis
Item
The subject is in good health as determined by medical and psychiatric history, physical examination, ECG, and serum chemistry, hematology, serology, and urinalysis results.
boolean
C0018759 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0748059 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C1883010 (UMLS CUI [6])
C0474523 (UMLS CUI [7])
C0036743 (UMLS CUI [8])
C0042014 (UMLS CUI [9])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Symptoms of sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder
Item
Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder.
boolean
C0037088 (UMLS CUI [1,1])
C0851578 (UMLS CUI [1,2])
C0033139 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,4])
C0037315 (UMLS CUI [2])
C0035258 (UMLS CUI [3])
C0813142 (UMLS CUI [4])
Significant Psychiatric Axis I except primary insomnia (by DSM-IV)
Item
Any clinically significant Axis I psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
boolean
C0270287 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0033139 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0220952 (UMLS CUI [2])
Recent mood or mental disorder causing insomnia by investigator judgement
Item
Subject has a recent history (12 months) of mood or other mental disorders that the investigator regards as accounting for the insomnia.
boolean
C0525045 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0917801 (UMLS CUI [1,4])
C0022423 (UMLS CUI [1,5])
C0008961 (UMLS CUI [1,6])
C0205394 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,4])
C0917801 (UMLS CUI [2,5])
C0022423 (UMLS CUI [2,6])
C0008961 (UMLS CUI [2,7])
Beck Depression Inventory Score
Item
Subject has a Beck Depression Inventory (Version II) [Beck, 1996] total score of 29 or greater at the Screening Visit (Visit 1) or at Visit 4 (if 2 weeks have elapsed between screening visit and randomization).
boolean
C2960571 (UMLS CUI [1])
Recent Alcohol, Narcotic, Benzodiazepine or other Substance Abuse except tobacco use (by DSM-IV criteria)
Item
History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence (with the exception of tobacco use) within the past 12 months as defined by DSM-IV-TR.
boolean
C0332185 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0524661 (UMLS CUI [2,2])
C0332185 (UMLS CUI [3,1])
C0338768 (UMLS CUI [3,2])
C0332185 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C0038580 (UMLS CUI [4,3])
C1705847 (UMLS CUI [4,4])
C0543414 (UMLS CUI [4,5])
C0220952 (UMLS CUI [5])
Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)
Item
Positive urine drug screen ( i.e. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) at Screening Visit (Visit 1). A repeat test will not be allowed if the result is positive.
boolean
C0743300 (UMLS CUI [1])
C0002667 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0006864 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0376196 (UMLS CUI [7])
Positive Alcohol Breath Test
Item
Positive alcohol breath test at Screening Visit (Visit l), i.e. alcohol level greater than 0.015% after subject being told that they must not drink for 8 hours preceding the Screening Visit (Visit I). A repeat test will not be allowed if the result is positive.
boolean
C1112499 (UMLS CUI [1])
History of neurological disorder (incl. dementia, cognitive disorder, significant head injury) or seizures (except febrile seizures)
Item
Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (except febrile seizure).
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0009241 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0018674 (UMLS CUI [4,2])
C1546944 (UMLS CUI [4,3])
C0262926 (UMLS CUI [5,1])
C0036572 (UMLS CUI [5,2])
C1705847 (UMLS CUI [5,3])
C0009952 (UMLS CUI [5,4])
Unstable Medical Disorder or disorder interfering pharmacodynamics/pharmacokinetics of vestipitant, safety or evaluation
Item
Subjects with an unstable medical disorder or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of vestipitant, may pose a safety concern, or interfere with accurate assessment of efficacy or safety.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2607417 (UMLS CUI [2,3])
C0243145 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2607417 (UMLS CUI [3,3])
C0031328 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0036043 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0220825 (UMLS CUI [5,3])
ECG Abnormalities by Sponsor criteria
Item
Subjects have any screening electrocardiography (ECG) parameter outside of the Sponsor-specified ranges as determined by a central ECG reader (See Appendix 2: ECG Parameters); the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the first screening PSG session (Visit 2).
boolean
C0522055 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
ECG Abnormalities by Investigator Judgement
Item
Subjects have any ECG finding that in the Investigator's judgement is considered to be clinically significant and not resolved by the first day of screening PSG session (Visit 2) (even if not outside of Sponsor-specified ranges in Appendix 2: ECG Parameters).
boolean
C0522055 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
HIV, Hepatitis B or Hepatitis C
Item
Known seropositivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Positive serum/urine pregnancy test, lactating or planning to become pregnant
Item
Women having a positive serum HCG pregnancy test at the Screening Visit (Visit 1), a positive urine pregnancy dipstick during the screening PSG session (Visit 2) or at Visit 4 (Randomization), or who are lactating or planning to become pregnant within 14 weeks following the Screening Visit (Visit 1).
boolean
C0430059 (UMLS CUI [1])
C0430063 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Laboratory Tests Abnormal by Sponsor criteria
Item
Subjects have any screening laboratory value outside of the Sponsorspecified ranges at the Screening Visit (Visit 1) (See Appendix 3: Laboratory Parameters). Testing may be repeated once to see if value returns to within range but any such laboratory abnormality must be resolved by the screening PSG session (Visit 2).
boolean
C0438215 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
Laboratory Results Abnormal by Investigator Judgement
Item
Subjects have any laboratory abnormality that in the Investigator's judgement is considered to be clinically significant and not resolved by the first day of the screening PSG session (Visit 2) (even if not outside of Sponsor-specified ranges in Appendix 3: Laboratory Parameters).
boolean
C0438215 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
Abnormal thyroid function
Item
Subjects who are not euthyroid based on laboratory tests at the screening visit. Subjects maintained on thyroid medication must be euthyroid for a period of at least 6 months prior to the Screening Visit (Visit 1), with no dose changes.
boolean
C0476414 (UMLS CUI [1])
BMI
Item
Body mass index of 34 or more at the Screening Visit (Visit 1).
boolean
C1305855 (UMLS CUI [1])
Apnea-hypopnea Index
Item
Apnea-hypopnea index of 10 or more on Night 1 screening PSG (Visit 2). Subjects failing Night I screening PSG should not be screened on Night 2 (Visit 3).
boolean
C2111846 (UMLS CUI [1])
Periodic Limb Movements with Arousal
Item
Periodic limb movements with arousal of 10 or more/hour of sleep on Night 1 screening PSG (Visit 2). Subjects failing Night 1 screening PSG should not be screened on Night 2 (Visit 3).
boolean
C1561887 (UMLS CUI [1,1])
C0003808 (UMLS CUI [1,2])
Recent or current nightshift or rotating shifts
Item
Nightshift or rotating shift-work within 1 month preceding the Screening Visit (Visit 1) or during the study period.
boolean
C0332185 (UMLS CUI [1,1])
C4505094 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C4505093 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C4505094 (UMLS CUI [3,2])
C0521116 (UMLS CUI [4,1])
C4505093 (UMLS CUI [4,2])
Recent or planned travel across time zones
Item
Planned travel across more than 3 time zones during the study or in the 2 weeks preceding the Screening Visit (Visit 1).
boolean
C1301732 (UMLS CUI [1,1])
C2825194 (UMLS CUI [1,2])
C0040802 (UMLS CUI [1,3])
C0040802 (UMLS CUI [2,1])
C2825194 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Regular Napping
Item
Regular napping, i.e. more than 2 naps per week.
boolean
C0870935 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Caffeine or Xanthine Consumption
Item
Consumption of beverages or foods containing a total of 300 mg or more per day on average of caffeine or other xanthines ( e.g. coffee, cola, tea, chocolate) over the one month preceding the Screening Visit (Visit 1)
boolean
C0948365 (UMLS CUI [1])
C0043314 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
Smoking Status or Nighttime smoking
Item
Smoking more than 1 pack of cigarettes (20) per day on average over the one month preceding the Screening Visit (Visit 1), or routinely a smoker during the night.
boolean
C1519386 (UMLS CUI [1])
C0037369 (UMLS CUI [2,1])
C0240526 (UMLS CUI [2,2])
Alcohol Consumption
Item
Typical consumption of more than 14 alcoholic units in any week, or more than 3 alcoholic units in any single day, over the one month preceding the Screening Visit (Visit 1)
boolean
C0001948 (UMLS CUI [1])
Use of Psychotropic Medications, e.g. benzodiazepines, anxiolytics, barbiturates, narcotics, or others incl. OTC drugs affecting sleep/wake function
Item
Use of any psychotropic medications, such as benzodiazepines and other anxiolytics, barbiturates, and narcotics, or other medications, including over-the-counter (OTC) products, that may affect sleep/wake function within 1 week or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1) or need to use any of these medications at any time during the study.
boolean
C0033978 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
C0004745 (UMLS CUI [4])
C0027415 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C4062291 (UMLS CUI [6,4])
C2709201 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C4062291 (UMLS CUI [7,4])
Recently started Cognitive Behavioral Therapy
Item
Cognitive Behavioral Therapy started within 1 month prior to the screening vis it ( i.e. within one month of Visit 1).
boolean
C0332185 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0009244 (UMLS CUI [1,3])
Chronic Systemic Corticosteroids, except inhaled corticosteroids in controlled asthma
Item
Has received chronic therapy with systemic corticosteroids within 12 months prior to the Screening Visit (Visit 1). Asthmatic subjects using an inhaled corticosteroid as part of their regular maintenance therapy are eligible provided their asthma is under control (especially as night).
boolean
C0205191 (UMLS CUI [1,1])
C4053960 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2911690 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
C2065041 (UMLS CUI [2,4])
Depot Neuroleptic Use
Item
Any history of depot neuroleptic use.
boolean
C2585377 (UMLS CUI [1])
Drugs (incl. OTC drugs and herbal products) metabolized by CYP3A4 or CYP3A4 inducers/inhibitors
Item
All other drugs metabolized via the P450 3A4 pathway and CYP3A4 inducers/inhibitors, including over-the-counter (OTC) and herbal products, must be discontinued from screening and are not allowed for the duration of the study (See Appendix 4).
boolean
C0013227 (UMLS CUI [1,1])
C1142644 (UMLS CUI [1,2])
C1524026 (UMLS CUI [1,3])
C1142644 (UMLS CUI [2,1])
C1524026 (UMLS CUI [2,2])
C0025125 (UMLS CUI [3,1])
C1142644 (UMLS CUI [3,2])
C1524026 (UMLS CUI [3,3])
C3830624 (UMLS CUI [4])
C3830625 (UMLS CUI [5])
Allergic Reaction or significant Adverse Effects to Vestipant or similar compounds
Item
Subjects who have a history of allergic reaction to, or significant adverse effects from vestipitant or closely related compounds.
boolean
C1527304 (UMLS CUI [1,1])
C2607417 (UMLS CUI [1,2])
C0750502 (UMLS CUI [2,1])
C0559546 (UMLS CUI [2,2])
C2607417 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C2607417 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C0750502 (UMLS CUI [4,1])
C0559546 (UMLS CUI [4,2])
C2607417 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
Hypersensitivity to NK1 Antagonists
Item
Subjects who have had hypersensitivity or intolerance to NK1 antagonists.
boolean
C0020517 (UMLS CUI [1,1])
C3543440 (UMLS CUI [1,2])
Drug or Device Trial Participation Status
Item
Subjects who are currently participating in a clinical trial in which the subject is or will be exposed to an investigational or noninvestigational drug or device, or have done so within the preceding 3 months.
boolean
C2348568 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0025080 (UMLS CUI [2,2])
Noncompliance expected in investigator's opinion
Item
Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
boolean
C0376405 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,4])
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