ID
38852
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 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 record the subject's demographics and should be filled out at Visit 1 (Screening).
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Keywords
Versions (3)
- 2/20/19 2/20/19 -
- 3/1/19 3/1/19 -
- 11/10/19 11/10/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 10, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Demography
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
If female, record child-bearing potential
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
If subject is female
Data type
text
Alias
- UMLS CUI [1]
- C3831118
Description
Ethnicity
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
African American/African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Description
American Indian or Alaskan Native
Data type
boolean
Alias
- UMLS CUI [1]
- C1515945
Description
Asian - Central/South Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Description
Asian - East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C4540996
Description
Asian - Japanase Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
Asian - South East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238697
Description
Native Hawaiian or Other Pacific Islander
Data type
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
White - Arabic/North African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Description
White - White/Caucasian/European Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0043157
Similar models
Demography
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])