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

  1. 2/20/19 2/20/19 -
  2. 3/1/19 3/1/19 -
  3. 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

  1. StudyEvent: ODM
    1. Demography
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Description

Date of Visit/Assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
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
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

If female, record child-bearing potential

Data type

text

Alias
UMLS CUI [1]
C0079399
Record child-bearing potential
Description

If subject is female

Data type

text

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
African American/African Heritage
Description

African American/African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

Asian - Central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

Asian - East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanase Heritage
Description

Asian - Japanase Heritage

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

Asian - South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

Native Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

White - Arabic/North African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
White - White/Caucasian/European Heritage
Description

White - White/Caucasian/European Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0043157

Similar models

Demography

  1. StudyEvent: ODM
    1. Demography
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
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
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Item
Record child-bearing potential
text
C3831118 (UMLS CUI [1])
Code List
Record child-bearing potential
CL Item
Post-menopausal (Post-menopausal)
CL Item
Potentially able to bear children (Potentially able to bear children)
CL Item
Sterile (of child-bearing age) (Sterile (of child-bearing age))
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
Hispanic or Latino (Hispanic or Latino)
CL Item
Not Hispanic or Latino (Not Hispanic or Latino)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanase Heritage
Item
Asian - Japanase Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
White - White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])

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