ID
38914
Descripción
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Palabras clave
Versiones (1)
- 12/11/19 12/11/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
12 de noviembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Type of Report
Alias
- UMLS CUI-1
- C0585733
Descripción
Randomisation
Alias
- UMLS CUI-1
- C0034656
Descripción
Serious adverse event Entry
Alias
- UMLS CUI-1
- C1519255
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
SAE Diagnosis or Sign/Symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C3540840
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826798
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1140263
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3898442
Descripción
Failed coding
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
Adverse Event Start Date/Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826806
Descripción
if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1705586
Descripción
if applicable
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826793
Descripción
SAE Maximum Intensity
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710066
Descripción
SAE Maximum Grade
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
Descripción
SAE Maximum Grade or Intensity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C1519255
Descripción
Action regarding Investigational Product
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1704758
Descripción
Subject withdrawal because of AE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Descripción
AE possibly caused by investigational product
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C0877248
Descripción
Duration of AE
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Tipo de datos
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
Descripción
SAE caused by activities related to study participation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1547644
Descripción
Seriousness
Alias
- UMLS CUI-1
- C0566251
- UMLS CUI-2
- C1547644
Descripción
Adverse Event Results in death
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1320832
Descripción
Adverse event is life-threatening
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1517874
Descripción
adverse event requires hospitalisation or prolongation of hospitalisation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Descripción
Serious adverse event results in disability/incapacity
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3176592
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0231170
- UMLS CUI [2,2]
- C1519255
Descripción
Serious adverse event: Congenital anomaly/birth defect
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Descripción
Other reason for event seriousness
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1519255
Descripción
Relevant concomitant/treatment medications
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0304229
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Descripción
(Trade Name preferred)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
Concomitant medication dose
Tipo de datos
float
Alias
- UMLS CUI [1]
- C2826811
Descripción
Concomitant medication unit
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826646
Descripción
Concomitant medication frequency
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826654
Descripción
Concomitant medication route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826730
Descripción
Concomitant Medication Start Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826734
Descripción
if no, specify End Date
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826666
Descripción
Concomitant medication end date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826744
Descripción
Concomitant Medication Primary Indication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826696
- UMLS CUI [1,2]
- C0205225
Descripción
Drug Type
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0457591
Descripción
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Descripción
Specific Condition
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Descripción
Date of onset
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0574845
Descripción
If no, specify date of last occurrence
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Descripción
Date of last disease occurence
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Descripción
Relevant Other Medical History / Risk Factors
Tipo de datos
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
Descripción
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Descripción
Lab Test Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0022885
Descripción
Test Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826247
Descripción
Laboratory Test Result
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0587081
Descripción
Laboratory Test Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Descripción
Normal Low Range
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1272773
Descripción
Normal High Range
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1299400
Descripción
Relevant other diagnostic laboratory results
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0205394
Descripción
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Descripción
Event recurrence after investigational product administered again
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Descripción
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Descripción
Non clinical
Alias
- UMLS CUI-1
- C1320722
Tipo de datos
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
Descripción
Receipt date by sponsoring company
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2985700
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013849
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Serious Adverse Event
- StudyEvent: ODM
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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])
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