ID
38933
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 whether and when Informed Consent has been obtained for PGx Pharmacogenetic Research.
Lien
https://clinicaltrials.gov/ct2/show/NCT00992160
Mots-clés
Versions (1)
- 14/11/2019 14/11/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
14 novembre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Pharmacogenetic Research Consent
- StudyEvent: ODM
Description
PGx-Pharmacogenetic research consent
Alias
- UMLS CUI-1
- C0021430
- UMLS CUI-2
- C2347500
Description
If Yes, please fill in the Date informed consent obtained for PGx-Pharmacogenetic research and if a blood sample has been collected in the following items. If No, record reason.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Description
Date informed consent obtained for Pharmacogenetic research
Type de données
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Description
If Yes, please record the date sample taken in the following item.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C2347500
Description
Date of sample taken of Pharmacogenetic research
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C2347500
Description
If other, specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C1882120
- UMLS CUI [1,3]
- C0021430
- UMLS CUI [1,4]
- C2347500
Description
Other reason for no informed consent obtained
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0021430
- UMLS CUI [1,4]
- C2347500
- UMLS CUI [1,5]
- C1882120
Similar models
Pharmacogenetic Research Consent
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C2347500 (UMLS CUI-2)
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C1882120 (UMLS CUI [1,5])