ID
38934
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 The purpose of this form is to record whether consent for PGx Pharmacogenetic Research has been withdrawn, and whether the sample was requested to be destroyed.
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Keywords
Versions (1)
- 11/14/19 11/14/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 14, 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
Pharmacogenetic Research Consent Withdrawal
- StudyEvent: ODM
Description
Withdrawal of consent for PGx (DNA) sample destruction
Alias
- UMLS CUI-1
- C1707492
- UMLS CUI-2
- C0031325
- UMLS CUI-3
- C0035168
- UMLS CUI-4
- C1948029
- UMLS CUI-5
- C0444245
Description
If yes, record date
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1707492
- UMLS CUI [1,2]
- C0031325
- UMLS CUI [1,3]
- C0035168
Description
If applicable
Data type
date
Alias
- UMLS CUI [1,1]
- C1707492
- UMLS CUI [1,2]
- C0031325
- UMLS CUI [1,3]
- C0035168
- UMLS CUI [1,4]
- C0011008
Description
If yes, record reason below
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1272683
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C0444245
Description
If other reason, specify below
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C1272683
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C0444245
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C1948029
- UMLS CUI [1,5]
- C0444245
Similar models
Pharmacogenetic Research Consent Withdrawal
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0031325 (UMLS CUI-2)
C0035168 (UMLS CUI-3)
C1948029 (UMLS CUI-4)
C0444245 (UMLS CUI-5)
C0031325 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
C0031325 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1948029 (UMLS CUI [1,2])
C0444245 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0444245 (UMLS CUI [1,4])
C3840932 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,4])
C0444245 (UMLS CUI [1,5])