ID
38865
Beschrijving
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 timing of the investigational product and to confirm the correct treatment at Visits 2, 3 and 8. There is a seperate form for the investigational product administered at Visits 4 to 7.
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Trefwoorden
Versies (1)
- 11-11-19 11-11-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 november 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Investigational Product and Treatment Confirmation
- StudyEvent: ODM
Beschrijving
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Beschrijving
If no, record reasons below
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C3827420
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Investigational Product and Treatment Confirmation
- StudyEvent: ODM
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C0087111 (UMLS CUI-2)
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C0087111 (UMLS CUI [1,2])
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