ID
38909
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 is used to record details about any possible suicidality-related adverse events happening during the study. The event must also be reported on the Adverse Events Form (Non-serious or Serious Adverse Events form as applicable) using the same terminology. Record only 1 event per form.
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Keywords
Versions (3)
- 11/12/19 11/12/19 -
- 11/12/19 11/12/19 -
- 11/12/19 11/12/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 12, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Possible Suicidality-Related Adverse Event
- StudyEvent: ODM
Description
Section 1
Alias
- UMLS CUI-1
- C1508263
- UMLS CUI-2
- C2732635
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C3166387
Description
Possible suicidality-related AE
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
Description
Possible suicidality-related AE start date
Data type
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
Description
Section 2. Brief description of possible Suicidality-Related Adverse Event
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C3166387
- UMLS CUI-3
- C0678257
Description
Section 3. Possible causes of possible suicidality-related adverse event
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2732635
- UMLS CUI-3
- C3166387
- UMLS CUI-4
- C0015127
Description
Possible causes of possible suicidality-related adverse event: Disease under study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2732635
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0012634
Description
Record in Section 8
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2732635
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2]
- C2347852
Description
Record in Section 8
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2732635
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2,1]
- C0004936
- UMLS CUI [2,2]
- C0009488
Description
Record in Section 8:
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2732635
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2]
- C0009488
Description
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2732635
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2]
- C0748073
Description
Possible causes of possible suicidality-related adverse event: Withdrawal of investigational product(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C2349954
Description
Possible causes of possible suicidality-related adverse event: Investigational product dose change
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1707811
Description
Possible causes of possible suicidality-related adverse event: Lack of efficacy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2]
- C0235828
Description
Possible causes of possible suicidality-related adverse event: Investigational product(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2732635
- UMLS CUI [1,3]
- C3166387
- UMLS CUI [1,4]
- C0015127
- UMLS CUI [2]
- C0304229
Description
If yes, specify
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2732635
- UMLS CUI [1,4]
- C3166387
- UMLS CUI [1,5]
- C0015127
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2732635
- UMLS CUI [1,4]
- C3166387
- UMLS CUI [1,5]
- C0205394
- UMLS CUI [1,6]
- C0015127
Description
Section 4. Provide Information
Alias
- UMLS CUI-1
- C0748059
Description
History of psychiatric conditions
Data type
boolean
Alias
- UMLS CUI [1]
- C0455498
Description
Previous suicidal ideation/behaviour or self-harm
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0424000
- UMLS CUI [1,2]
- C0205156
- UMLS CUI [2,1]
- C0205156
- UMLS CUI [2,2]
- C1760428
- UMLS CUI [3,1]
- C0424366
- UMLS CUI [3,2]
- C0205156
Description
Current use of iIllicit drugs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0086190
- UMLS CUI [1,2]
- C0521116
Description
Current alcohol consumption
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0521116
Description
Family history of suicidality
Data type
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C3166387
Description
Family history of psychiatric disorders
Data type
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0004936
Description
Section 5. Provide information on the subject's current psycho-social stressors
Alias
- UMLS CUI-1
- C0748073
Description
Section 6. Relevant and/or recent suicidal ideation
Alias
- UMLS CUI-1
- C0424000
Description
Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal bebavior, as assessed by the investigator, for this index event i.e., provide details, including any suicidal thoughts, and associated frequency, severity and duration, as well as likelihood of the subject acting upon these thoughts.
Data type
text
Alias
- UMLS CUI [1,1]
- C0424000
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0424000
- UMLS CUI [2,2]
- C0750502
Description
Section 7. Suicidal behaviour present during study
Alias
- UMLS CUI-1
- C1760428
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C2347804
Description
Provide information on any suicidal behaviour present during the study, as assessed by the investigator, for this index event, i.e. Details of any suicidal behaviour, iincluding any plan, preparations, and/or attempt Description of the associated frequency, severity and duration of these behaviours Likelihood of the subject acting upon plans and preparations If possible, description of the subject's intent (or evidence of attention seeking behaviour) Description of the degree of impulsivity or premeditation Description of the subject's mood and thoughts before and after the behaviour
Data type
text
Alias
- UMLS CUI [1,1]
- C1760428
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Description
Section 8. Comments on medical and psychiatric treatment
Alias
- UMLS CUI-1
- C0237726
- UMLS CUI-3
- C0204523
Similar models
Possible Suicidality-Related Adverse Event
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C2732635 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C3166387 (UMLS CUI-4)
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C3166387 (UMLS CUI-2)
C0678257 (UMLS CUI-3)
C3166387 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
C0015127 (UMLS CUI-4)
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0008976 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C2347852 (UMLS CUI [2])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0748073 (UMLS CUI [2])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2,1])
C1707811 (UMLS CUI [2,2])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0235828 (UMLS CUI [2])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2])
C0877248 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,3])
C3166387 (UMLS CUI [1,4])
C0015127 (UMLS CUI [1,5])
C0877248 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,3])
C3166387 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0015127 (UMLS CUI [1,6])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [2,1])
C1760428 (UMLS CUI [2,2])
C0424366 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0347984 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0204523 (UMLS CUI-3)
C0204523 (UMLS CUI [2])