ID

35342

Beschreibung

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 The purpose of this form is to check for the subjects eligibility and should be filled out at visit 1.

Link

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

Stichworte

Versionen (3)
  1. 01.03.19 01.03.19 -
  2. 12.11.19 12.11.19 -
  3. 12.11.19 12.11.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. März 2019

DOI

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Lizenz

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

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Beschreibung

Administrative Data

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

Date of Visit/Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Beschreibung

Patient No.

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Eligibility Criteria
Beschreibung

Eligibility Criteria

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
The subject must be able to read and understand the informed consent fonn and provide written infonned 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.
Beschreibung

Able to Read and Understand Informed Consent

Datentyp

boolean

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

Gender and Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
Diagnosis of Primary Insomnia, based on Diagnostic and Statistical Manual of Mental Disorders.
Beschreibung

Text Revision (DSM-JV-TR) criteria 307.42 • 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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332137
UMLS CUI [1,2]
C0393760
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.
Beschreibung

Self Reported Sleep History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2700446
UMLS CUI [1,2]
C0037317
Time in bed between 6.5 and 8.5 hours for least 5 nights per week over the preceding 3 months.
Beschreibung

Time in Bed

Datentyp

boolean

Alias
UMLS CUI [1]
C4289366
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).
Beschreibung

Bed Time

Datentyp

boolean

Alias
UMLS CUI [1]
C0521112
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
Beschreibung

Sleep Variables from Polysomnography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162701
UMLS CUI [1,2]
C0037317
A female subject is ehgible 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.
Beschreibung

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 stin11Ulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].

Datentyp

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
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.
Beschreibung

Health Status

Datentyp

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
Beschreibung

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.
Beschreibung

Symptoms of Sleep Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0851578
UMLS CUI [2,1]
C0033139
UMLS CUI [2,2]
C0332300
UMLS CUI [3]
C0037315
UMLS CUI [4]
C0035258
UMLS CUI [5]
C0813142
Any clinically significant Axis I psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
Beschreibung

Clinically Significant Psychiatric Disorder Axis I

Datentyp

boolean

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

History of Mental Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C0917801
Subject has a Beck Depression Inventory (Version II) [Beck, 1996] total score of29 or greater at the Screening Visit (Visit l) or at Visit 4 (if2 weeks have elapsed between screening visit and randomization).
Beschreibung

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

Datentyp

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 DSMIV-TR.
Beschreibung

History of Substance Abuse, Alcohol, Narcotic, Benzodiazepine

Datentyp

boolean

Alias
UMLS CUI [1]
C1299544
UMLS CUI [2]
C0085762
UMLS CUI [3]
C0524661
UMLS CUI [4]
C0005064
UMLS CUI [5]
C0038580
Positive urine drug screen ( i.e. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) at Screening Visit (Visit I ). A repeat test will not be allowed if the result is positive.
Beschreibung

Positive Urine Drug Screens

Datentyp

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
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.
Beschreibung

Positive Alcohol Breath Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0202306
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).
Beschreibung

History of Neurological Abnormality or History of Seizure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036572
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0262926
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.
Beschreibung

Unstable Medical Disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0000854
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C1378698
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C0025519
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0036043
UMLS CUI [6,1]
C0521102
UMLS CUI [6,2]
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 abnonnality must be resolved by the first screening PSG session (Visit 2).
Beschreibung

ECG Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
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 Sponsorspecified ranges in Appendix 2: ECG Parameters).
Beschreibung

ECG Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
Known seropositivity for human immunodeficiency virus (HfV), Hepatitis B, or Hepatitis C.
Beschreibung

HIV, Hepatitis B or Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
Women having a positive serum HCG pregnancy test at the Screening Visit (Visit l), a positive urine pregnancy dipstick during the screening PSG sessEon (Visit 2) or at Visit 4 (Randomization), or who are lactating or planning to become pregnant within 14 weeks following the Screening Visit (Visit I).
Beschreibung

Positive Serum HCG Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0430060
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).
Beschreibung

Laboratory Tests Abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
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).
Beschreibung

Laboratory Results Abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1704258
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 I), with no dose changes.
Beschreibung

Euthyroid

Datentyp

boolean

Alias
UMLS CUI [1]
C0117002
Body mass index of 34 or more at the Screening Visit (Visit I).
Beschreibung

BMI

Datentyp

boolean

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

Apnea-hypopnea Index

Datentyp

boolean

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

Periodic Limb Movements with Arousal

Datentyp

boolean

Alias
UMLS CUI [1]
C0596840
UMLS CUI [2]
C0003808
Nightshift or rotating shift-work within I month preceding the Screening Visit (Visit I) or during the study period.
Beschreibung

Recent Nightshift or Rotating Shift

Datentyp

boolean

Alias
UMLS CUI [1]
C1658633
UMLS CUI [2]
C0555008
Planned travel across more than 3 time zones during the study or in the 2 weeks preceding the Screening Visit (Visit I).
Beschreibung

Planned Long Distance Travel

Datentyp

boolean

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

Regular Napping

Datentyp

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 I)
Beschreibung

Note: 360 mL soda = - 50mg, 210 mL coffee or 60 mL espresso = - I 00mg, 21 OmL tea = -7 5mg caffeine].

Datentyp

boolean

Alias
UMLS CUI [1]
C0948365
UMLS CUI [2]
C0043314
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.
Beschreibung

Smoking Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1519386
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 L)
Beschreibung

(Note: I unit= 240mL beer, 90mL wine, or 30mL hard liquor].

Datentyp

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 I week or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit I) or need to use any of these medications at any time during the study.
Beschreibung

Use of Psychotropic Medications

Datentyp

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 [7,1]
C2709201
UMLS CUI [7,2]
C0013227
Cognitive Behavioral Therapy started within 1 month prior to the screening vis it ( i.e. within one month of Visit I).
Beschreibung

Recent Cognitive Behavioral Therapy

Datentyp

boolean

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

Chronic or Systemic Corticosteroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0220922
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0004096
Any history of depot neuroleptic use.
Beschreibung

History of Depot Neuroleptic Use

Datentyp

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).
Beschreibung

Drugs Metabolized by CYP3A4

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1142644
UMLS CUI [1,3]
C1524026
UMLS CUI [2,1]
C3830624
UMLS CUI [2,2]
C3830625
UMLS CUI [3,1]
C2709201
UMLS CUI [3,2]
C0013227
Subjects who have a history of allergic reaction to, or significant adverse effects from vestipitant or closely related compounds.
Beschreibung

History of Allergic Reaction or Adverse Effects to Vestipant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0013230
Subjects who have had hypersensitivity or intolerance to NK1 antagonists.
Beschreibung

Hypersensitivity to NK1 Antagonists

Datentyp

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.
Beschreibung

Clinical Trial Participation Status

Datentyp

boolean

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

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
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Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient No.
Item
Patient No.
text
C1830427 (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 and Understand Informed Consent
Item
The subject must be able to read and understand the informed consent fonn and provide written infonned 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])
C0162340 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
Gender and Age
Item
Male and female subjects 18 through 64 years of age (inclusive).
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Diagnosis of Primary Insomnia
Item
Diagnosis of Primary Insomnia, based on Diagnostic and Statistical Manual of Mental Disorders.
boolean
C0332137 (UMLS CUI [1,1])
C0393760 (UMLS CUI [1,2])
Self Reported Sleep History
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])
C0037317 (UMLS CUI [1,2])
Time 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
C4289366 (UMLS CUI [1])
Bed Time
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
C0521112 (UMLS CUI [1])
Sleep Variables from Polysomnography
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])
C0037317 (UMLS CUI [1,2])
Child Bearing Potential, Use of Contraception
Item
A female subject is ehgible 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
C1960468 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Health Status
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
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
C0851578 (UMLS CUI [1])
C0033139 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0037315 (UMLS CUI [3])
C0035258 (UMLS CUI [4])
C0813142 (UMLS CUI [5])
Clinically Significant Psychiatric Disorder Axis I
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])
History of Mental Disorders
Item
Subject has a recent history (12 months) of mood or other mental disorders that the investigator regards as accounting for the insomnia.
boolean
C0004936 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C0917801 (UMLS CUI [2,2])
Beck Depression Inventory Score
Item
Subject has a Beck Depression Inventory (Version II) [Beck, 1996] total score of29 or greater at the Screening Visit (Visit l) or at Visit 4 (if2 weeks have elapsed between screening visit and randomization).
boolean
C2960571 (UMLS CUI [1])
History of Substance Abuse, Alcohol, Narcotic, Benzodiazepine
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 DSMIV-TR.
boolean
C1299544 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0524661 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0038580 (UMLS CUI [5])
Positive Urine Drug Screens
Item
Positive urine drug screen ( i.e. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) at Screening Visit (Visit I ). 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])
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
C0202306 (UMLS CUI [1])
History of Neurological Abnormality or History of Seizure
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])
C0036572 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Unstable Medical Disorder
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
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0000854 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C1378698 (UMLS CUI [3,2])
C0521102 (UMLS CUI [4,1])
C0025519 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C0036043 (UMLS CUI [5,2])
C0521102 (UMLS CUI [6,1])
C0220825 (UMLS CUI [6,2])
ECG Abnormalities
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 abnonnality must be resolved by the first screening PSG session (Visit 2).
boolean
C0522055 (UMLS CUI [1])
ECG Abnormalities
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 Sponsorspecified ranges in Appendix 2: ECG Parameters).
boolean
C0522055 (UMLS CUI [1])
HIV, Hepatitis B or Hepatitis C
Item
Known seropositivity for human immunodeficiency virus (HfV), Hepatitis B, or Hepatitis C.
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Positive Serum HCG Test
Item
Women having a positive serum HCG pregnancy test at the Screening Visit (Visit l), a positive urine pregnancy dipstick during the screening PSG sessEon (Visit 2) or at Visit 4 (Randomization), or who are lactating or planning to become pregnant within 14 weeks following the Screening Visit (Visit I).
boolean
C0430060 (UMLS CUI [1])
Laboratory Tests Abnormal
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])
Laboratory Results Abnormality
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
C1254595 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Euthyroid
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 I), with no dose changes.
boolean
C0117002 (UMLS CUI [1])
BMI
Item
Body mass index of 34 or more at the Screening Visit (Visit I).
boolean
C1305855 (UMLS CUI [1])
Apnea-hypopnea Index
Item
Apnea-hypopnea index of IO or more on Night I 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 I screening PSG (Visit 2). Subj ects failing Night I screening PSG should not be screened on Night 2 (Visit 3).
boolean
C0596840 (UMLS CUI [1])
C0003808 (UMLS CUI [2])
Recent Nightshift or Rotating Shift
Item
Nightshift or rotating shift-work within I month preceding the Screening Visit (Visit I) or during the study period.
boolean
C1658633 (UMLS CUI [1])
C0555008 (UMLS CUI [2])
Planned Long Distance Travel
Item
Planned travel across more than 3 time zones during the study or in the 2 weeks preceding the Screening Visit (Visit I).
boolean
C0040802 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
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 I)
boolean
C0948365 (UMLS CUI [1])
C0043314 (UMLS CUI [2])
Smoking Status
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])
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 L)
boolean
C0001948 (UMLS CUI [1])
Use of Psychotropic Medications
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 I week or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit I) 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])
C2709201 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
Recent Cognitive Behavioral Therapy
Item
Cognitive Behavioral Therapy started within 1 month prior to the screening vis it ( i.e. within one month of Visit I).
boolean
C0009244 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Chronic or Systemic Corticosteroids
Item
Has received chronic therapy with systemic corticosteroids within 12 months prior to the Screening Vis it (Vis it I). 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
C0001617 (UMLS CUI [1,1])
C0220922 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
History of Depot Neuroleptic Use
Item
Any history of depot neuroleptic use.
boolean
C2585377 (UMLS CUI [1])
Drugs Metabolized by CYP3A4
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])
C3830624 (UMLS CUI [2,1])
C3830625 (UMLS CUI [2,2])
C2709201 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
History of Allergic Reaction or Adverse Effects to Vestipant
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])
C0013230 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
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])
Clinical 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])
Protocol Compliance
Item
Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
boolean
C0525058 (UMLS CUI [1])
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