ID
38914
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). This form should be filled in in case of a serious adverse event.
Lien
https://clinicaltrials.gov/ct2/show/NCT00992160
Mots-clés
Versions (1)
- 12/11/2019 12/11/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
12 novembre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Serious Adverse Event
- StudyEvent: ODM
Description
Type of Report
Alias
- UMLS CUI-1
- C0585733
Description
Randomisation
Alias
- UMLS CUI-1
- C0034656
Description
Serious adverse event Entry
Alias
- UMLS CUI-1
- C1519255
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
SAE Diagnosis or Sign/Symptom
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C3540840
Type de données
text
Alias
- UMLS CUI [1]
- C2826798
Type de données
text
Alias
- UMLS CUI [1]
- C1140263
Type de données
text
Alias
- UMLS CUI [1]
- C3898442
Description
Failed coding
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Adverse Event Start Date/Time
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826806
Description
if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death
Type de données
text
Alias
- UMLS CUI [1]
- C1705586
Description
if applicable
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826793
Description
SAE Maximum Intensity
Type de données
text
Alias
- UMLS CUI [1]
- C1710066
Description
SAE Maximum Grade
Type de données
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
Description
SAE Maximum Grade or Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C1519255
Description
Action regarding Investigational Product
Type de données
text
Alias
- UMLS CUI [1]
- C1704758
Description
Subject withdrawal because of AE
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Description
AE possibly caused by investigational product
Type de données
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C0877248
Description
Duration of AE
Type de données
time
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Type de données
time
Alias
- UMLS CUI [1,1]
- C1272706
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0439659
- UMLS CUI [1,5]
- C1519255
Description
SAE caused by activities related to study participation
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Type de données
text
Alias
- UMLS CUI [1]
- C1547644
Description
Seriousness
Alias
- UMLS CUI-1
- C0566251
- UMLS CUI-2
- C1547644
Description
Adverse Event Results in death
Type de données
boolean
Alias
- UMLS CUI [1]
- C1320832
Description
Adverse event is life-threatening
Type de données
boolean
Alias
- UMLS CUI [1]
- C1517874
Description
adverse event requires hospitalisation or prolongation of hospitalisation
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Description
Serious adverse event results in disability/incapacity
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3176592
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0231170
- UMLS CUI [2,2]
- C1519255
Description
Serious adverse event: Congenital anomaly/birth defect
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Description
Other reason for event seriousness
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1519255
Description
Relevant concomitant/treatment medications
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0304229
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Description
(Trade Name preferred)
Type de données
text
Alias
- UMLS CUI [1]
- C2360065
Description
Concomitant medication dose
Type de données
float
Alias
- UMLS CUI [1]
- C2826811
Description
Concomitant medication unit
Type de données
text
Alias
- UMLS CUI [1]
- C2826646
Description
Concomitant medication frequency
Type de données
text
Alias
- UMLS CUI [1]
- C2826654
Description
Concomitant medication route
Type de données
text
Alias
- UMLS CUI [1]
- C2826730
Description
Concomitant Medication Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
if no, specify End Date
Type de données
text
Alias
- UMLS CUI [1]
- C2826666
Description
Concomitant medication end date
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant Medication Primary Indication
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826696
- UMLS CUI [1,2]
- C0205225
Description
Drug Type
Type de données
text
Alias
- UMLS CUI [1]
- C0457591
Description
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Specific Condition
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Date of onset
Type de données
date
Alias
- UMLS CUI [1]
- C0574845
Description
If no, specify date of last occurrence
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
Date of last disease occurence
Type de données
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Description
Relevant Other Medical History / Risk Factors
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [2,1]
- C2347946
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0035648
Description
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Lab Test Name
Type de données
text
Alias
- UMLS CUI [1]
- C0022885
Description
Test Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826247
Description
Laboratory Test Result
Type de données
text
Alias
- UMLS CUI [1]
- C0587081
Description
Laboratory Test Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Type de données
text
Alias
- UMLS CUI [1]
- C1272773
Description
Normal High Range
Type de données
text
Alias
- UMLS CUI [1]
- C1299400
Description
Relevant other diagnostic laboratory results
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0205394
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Event recurrence after investigational product administered again
Type de données
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Description
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Description
Non clinical
Alias
- UMLS CUI-1
- C1320722
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C0205257
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
- UMLS CUI [1,5]
- C2347796
Description
Receipt date by sponsoring company
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Type de données
text
Alias
- UMLS CUI [1]
- C2985700
Type de données
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Type de données
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Type de données
text
Alias
- UMLS CUI [1]
- C0013849
Similar models
Serious Adverse Event
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0205265 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C0231175 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2347946 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
C2347796 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,2])