ID

38888

Descrizione

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 information on pharmacokinetic blood samples taken at Visits 4 through to 8 (two samples at Visits 7 and 8).

collegamento

https://clinicaltrials.gov/ct2/show/NCT00992160

Keywords

  1. 12/11/19 12/11/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

12 novembre 2019

DOI

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Licenza

Creative Commons BY-NC 3.0

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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Pharmacokinetics Blood

  1. StudyEvent: ODM
    1. Pharmacokinetics Blood
Administrative Data
Descrizione

Administrative Data

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

Date of Visit/Assessment

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Descrizione

Study site

Tipo di dati

text

Alias
UMLS CUI [1]
C2825164
Patient
Descrizione

Patient

Tipo di dati

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Descrizione

Subject No.

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Study Visit
Descrizione

Type of Visit

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing Date and Time
Descrizione

Dosing Date and Time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Dosing date/time
Descrizione

Dosing date/time

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Pharmacokinetics Blood
Descrizione

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Scheduled Time
Descrizione

At Visit 4 and 5, select "10h". At Visit 6, select "Visit". At Visit 7 and 8, fill in entire itemgroup both for "Pre-dose" and "10h".

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1301732
Actual date/time
Descrizione

Date/time of pharmacokinetic blood sample

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1264639
Sample identifier
Descrizione

Pharmacokinetic blood sample identifier

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1299222

Similar models

Pharmacokinetics Blood

  1. StudyEvent: ODM
    1. Pharmacokinetics Blood
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Study Visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Study Visit
CL Item
Visit 4 (Visit 4)
CL Item
Visit 5 (Visit 5)
CL Item
Visit 6 (Visit 6)
CL Item
Visit 7 (Visit 7)
CL Item
Visit 8 (Visit 8)
Item Group
Dosing Date and Time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Scheduled Time
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
CL Item
10h (10h)
CL Item
Visit (Visit)
CL Item
Pre-dose (Pre-dose)
Date/time of pharmacokinetic blood sample
Item
Actual date/time
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Pharmacokinetic blood sample identifier
Item
Sample identifier
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])

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