ID
35342
Description
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.
Lien
https://clinicaltrials.gov/ct2/show/NCT00992160
Mots-clés
Versions (3)
- 01/03/2019 01/03/2019 -
- 12/11/2019 12/11/2019 -
- 12/11/2019 12/11/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
1 mars 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Eligibility Criteria
- StudyEvent: ODM
Description
Eligibility Criteria
Alias
- UMLS CUI-1
- C1516637
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Able to Read and Understand Informed Consent
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0586740
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0162340
- UMLS CUI [2]
- C0525058
Description
Gender and Age
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0079399
- UMLS CUI [1,2]
- C0001779
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0332137
- UMLS CUI [1,2]
- C0393760
Description
Self Reported Sleep History
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2700446
- UMLS CUI [1,2]
- C0037317
Description
Time in Bed
Type de données
boolean
Alias
- UMLS CUI [1]
- C4289366
Description
Bed Time
Type de données
boolean
Alias
- UMLS CUI [1]
- C0521112
Description
Sleep Variables from Polysomnography
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0162701
- UMLS CUI [1,2]
- C0037317
Description
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].
Type de données
boolean
Alias
- UMLS CUI [1]
- C1960468
- UMLS CUI [2,1]
- C1524063
- UMLS CUI [2,2]
- C0700589
Description
Health Status
Type de données
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
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Symptoms of Sleep Disorder
Type de données
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
Description
Clinically Significant Psychiatric Disorder Axis I
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0270287
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [1,3]
- C0750502
Description
History of Mental Disorders
Type de données
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
Description
Patients scoring 17 to 28 must he confirmed to not have major depressive illness to be eligible.
Type de données
boolean
Alias
- UMLS CUI [1]
- C2960571
Description
History of Substance Abuse, Alcohol, Narcotic, Benzodiazepine
Type de données
boolean
Alias
- UMLS CUI [1]
- C1299544
- UMLS CUI [2]
- C0085762
- UMLS CUI [3]
- C0524661
- UMLS CUI [4]
- C0005064
- UMLS CUI [5]
- C0038580
Description
Positive Urine Drug Screens
Type de données
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
Description
Positive Alcohol Breath Test
Type de données
boolean
Alias
- UMLS CUI [1]
- C0202306
Description
History of Neurological Abnormality or History of Seizure
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0036572
- UMLS CUI [2,1]
- C0027765
- UMLS CUI [2,2]
- C0262926
Description
Unstable Medical Disorder
Type de données
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
Description
ECG Abnormalities
Type de données
boolean
Alias
- UMLS CUI [1]
- C0522055
Description
ECG Abnormalities
Type de données
boolean
Alias
- UMLS CUI [1]
- C0522055
Description
HIV, Hepatitis B or Hepatitis C
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Description
Positive Serum HCG Test
Type de données
boolean
Alias
- UMLS CUI [1]
- C0430060
Description
Laboratory Tests Abnormal
Type de données
boolean
Alias
- UMLS CUI [1]
- C0438215
Description
Laboratory Results Abnormality
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1704258
Description
Euthyroid
Type de données
boolean
Alias
- UMLS CUI [1]
- C0117002
Description
BMI
Type de données
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
Apnea-hypopnea Index
Type de données
boolean
Alias
- UMLS CUI [1]
- C2111846
Description
Periodic Limb Movements with Arousal
Type de données
boolean
Alias
- UMLS CUI [1]
- C0596840
- UMLS CUI [2]
- C0003808
Description
Recent Nightshift or Rotating Shift
Type de données
boolean
Alias
- UMLS CUI [1]
- C1658633
- UMLS CUI [2]
- C0555008
Description
Planned Long Distance Travel
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0040802
- UMLS CUI [1,2]
- C1301732
Description
Regular Napping
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0870935
- UMLS CUI [1,2]
- C0205272
Description
Note: 360 mL soda = - 50mg, 210 mL coffee or 60 mL espresso = - I 00mg, 21 OmL tea = -7 5mg caffeine].
Type de données
boolean
Alias
- UMLS CUI [1]
- C0948365
- UMLS CUI [2]
- C0043314
Description
Smoking Status
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519386
Description
(Note: I unit= 240mL beer, 90mL wine, or 30mL hard liquor].
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
Use of Psychotropic Medications
Type de données
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
Description
Recent Cognitive Behavioral Therapy
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0009244
- UMLS CUI [1,2]
- C0332185
Description
Chronic or Systemic Corticosteroids
Type de données
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
Description
History of Depot Neuroleptic Use
Type de données
boolean
Alias
- UMLS CUI [1]
- C2585377
Description
Drugs Metabolized by CYP3A4
Type de données
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
Description
History of Allergic Reaction or Adverse Effects to Vestipant
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1527304
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [2,1]
- C0559546
- UMLS CUI [2,2]
- C0013230
Description
Hypersensitivity to NK1 Antagonists
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C3543440
Description
Clinical Trial Participation Status
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Protocol Compliance
Type de données
boolean
Alias
- UMLS CUI [1]
- C0525058
Similar models
Eligibility Criteria
- StudyEvent: ODM
C2985720 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
C0001779 (UMLS CUI [1,2])
C0393760 (UMLS CUI [1,2])
C0037317 (UMLS CUI [1,2])
C0037317 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
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])
C0033139 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0037315 (UMLS CUI [3])
C0035258 (UMLS CUI [4])
C0813142 (UMLS CUI [5])
C0004936 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C0917801 (UMLS CUI [2,2])
C0085762 (UMLS CUI [2])
C0524661 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0038580 (UMLS CUI [5])
C0002667 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0006864 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0036572 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
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])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0003808 (UMLS CUI [2])
C0555008 (UMLS CUI [2])
C1301732 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,2])
C0043314 (UMLS CUI [2])
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])
C0332185 (UMLS CUI [1,2])
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])
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])
C0013230 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C3543440 (UMLS CUI [1,2])