ID
38910
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). 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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00992160
Nyckelord
Versioner (2)
- 2019-11-12 2019-11-12 -
- 2019-11-12 2019-11-12 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
12 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
Logs and Repeats
- StudyEvent: ODM
Beskrivning
Date of visit/assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beskrivning
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
Beskrivning
Concomitant medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Non-serious adverse events
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Serious adverse events
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Repeat haematology or clinical chemistry samples taken
Datatyp
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
Beskrivning
Repeat urinalysis samples
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0042014
Beskrivning
Repeat ECGs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Beskrivning
Repeat vital signs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0518766
Beskrivning
Possible suicidality-related adverse event
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
Beskrivning
Liver Event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
If Yes to Liver Events, complete the Liver Event forms
Datatyp
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
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
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])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
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])