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