ID
38910
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). This form is to be filled in at the end of the study (regular Day 14 Follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Keywords
Versions (2)
- 11/12/19 11/12/19 -
- 11/12/19 11/12/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 12, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Logs and Repeats
- StudyEvent: ODM
Description
Date of visit/assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0205341
- UMLS CUI-4
- C0220825
Description
Concomitant medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Non-serious adverse events
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
Serious adverse events
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Repeat haematology or clinical chemistry samples taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
- UMLS CUI [2,3]
- C0205341
Description
Repeat urinalysis samples
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0042014
Description
Repeat ECGs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Description
Repeat vital signs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0518766
Description
Possible suicidality-related adverse event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
Description
Liver Event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
If Yes to Liver Events, complete the Liver Event forms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Similar models
Logs and Repeats
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])