ID
38853
Beskrivning
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 subjects current medical conditions and should be filled out at Visit 1 (Screening) and Visit 2.
Länk
https://clinicaltrials.gov/ct2/show/NCT00992160
Nyckelord
Versioner (3)
- 2019-02-23 2019-02-23 -
- 2019-03-01 2019-03-01 -
- 2019-11-10 2019-11-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
10 november 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Medical Conditions
- StudyEvent: ODM
Beskrivning
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
Beskrivning
Fill in this item group repeatedly for each MedDRA System Organ Class
Datatyp
integer
Alias
- UMLS CUI [1]
- C2347091
Beskrivning
Check only one response for each MedDRA System Organ Class
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0332307
Similar models
Medical Conditions
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])