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

  1. 11/12/19 11/12/19 -
  2. 11/12/19 11/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 12, 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

Logs and Repeats

  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Description

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/Assessment
Description

Date is the start of the study for this subject

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
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
Were any concomitant medications taken by the subject during the study?
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious adverse events

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

Serious adverse events

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Were any repeat haematology or clinical chemistry samples taken?
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
Were any repeat urinalysis samples taken?
Description

Repeat urinalysis samples

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0042014
Were any repeat ECGs performed?
Description

Repeat ECGs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Description

Repeat vital signs

Data type

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0518766
Did the subject experience any possible suicidality-related adverse events during the study?
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
Liver Event
Description

Liver Event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
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

  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Concomitant medication
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0008000 (UMLS CUI [1,1])
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])
Repeat urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0200345 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Repeat ECGs
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Repeat vital signs
Item
Were any repeat vital signs recorded?
boolean
C0205341 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Possible suicidality-related adverse event
Item
Did the subject experience any possible suicidality-related adverse events during the study?
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
Item Group
Liver Event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver chemistry results reached investigational product stopping criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
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])

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