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38909

Beschreibung

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

Stichworte

Versionen (3)
  1. 12.11.19 12.11.19 -
  2. 12.11.19 12.11.19 -
  3. 12.11.19 12.11.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. November 2019

DOI

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Creative Commons BY-NC 3.0
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    Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

    Englisch

    Possible Suicidality-Related Adverse Event

    1 Formulare  
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of Visit/Assessment
    Beschreibung

    Date of Visit/Assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Site
    Beschreibung

    Study site

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Beschreibung

    Patient

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient No.
    Beschreibung

    Subject No.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Section 1
    Beschreibung

    Section 1

    Alias
    UMLS CUI-1
    C1508263
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C0877248
    UMLS CUI-4
    C3166387
    Possible suicidality related AE
    Beschreibung

    Possible suicidality-related AE

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2732635
    UMLS CUI [1,3]
    C3166387
    Start Date
    Beschreibung

    Possible suicidality-related AE start date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2697888
    UMLS CUI [1,2]
    C2732635
    UMLS CUI [1,3]
    C3166387
    Section 2. Brief description of possible Suicidality-Related Adverse Event
    Beschreibung

    Section 2. Brief description of possible Suicidality-Related Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C3166387
    UMLS CUI-3
    C0678257
    Brief description of possible suicidality-related AE
    Beschreibung

    Provide a Brief Description of the Possible Suicidality-Related Adverse Event

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C3166387
    UMLS CUI [1,3]
    C0678257
    Section 3. Possible causes of possible suicidality-related adverse event
    Beschreibung

    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
    Disease under study
    Beschreibung

    Possible causes of possible suicidality-related adverse event: Disease under study

    Datentyp

    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
    Concomitant medications
    Beschreibung

    Record in Section 8

    Datentyp

    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
    Comorbid psychiatric condition(s)
    Beschreibung

    Record in Section 8

    Datentyp

    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
    Medical condition(s)
    Beschreibung

    Record in Section 8:

    Datentyp

    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
    Psycho-social stressors
    Beschreibung

    Possible causes of possible suicidality-related adverse event: Psycho-social stressors

    Datentyp

    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
    Withdrawal of investigational product(s)
    Beschreibung

    Possible causes of possible suicidality-related adverse event: Withdrawal of investigational product(s)

    Datentyp

    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
    Investigational product dose change
    Beschreibung

    Possible causes of possible suicidality-related adverse event: Investigational product dose change

    Datentyp

    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
    Lack of efficacy
    Beschreibung

    Possible causes of possible suicidality-related adverse event: Lack of efficacy

    Datentyp

    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
    Investigational product(s)
    Beschreibung

    Possible causes of possible suicidality-related adverse event: Investigational product(s)

    Datentyp

    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
    Other
    Beschreibung

    If yes, specify

    Datentyp

    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
    Other, specify
    Beschreibung

    if applicable

    Datentyp

    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
    Section 4. Provide Information
    Beschreibung

    Section 4. Provide Information

    Alias
    UMLS CUI-1
    C0748059
    Has the subject had any psychiatric conditions in the past?
    Beschreibung

    History of psychiatric conditions

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0455498
    Has the subject had any suicidal ideation, behaviour or self-harm in the past?
    Beschreibung

    Previous suicidal ideation/behaviour or self-harm

    Datentyp

    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
    Subject's current use of llicit drugs?
    Beschreibung

    Current use of iIllicit drugs

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0086190
    UMLS CUI [1,2]
    C0521116
    Subject's current use of alcohol?
    Beschreibung

    Current alcohol consumption

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0521116
    Family history of suicidality?
    Beschreibung

    Family history of suicidality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C3166387
    Family history of psychiatric disorders?
    Beschreibung

    Family history of psychiatric disorders

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0004936
    Section 5. Provide information on the subject's current psycho-social stressors
    Beschreibung

    Section 5. Provide information on the subject's current psycho-social stressors

    Alias
    UMLS CUI-1
    C0748073
    Provide information on the subject's current psycho-social stressors
    Beschreibung

    For example, isolation, problems with family, relationships, work, finances, stress, etc.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0748073
    UMLS CUI [1,2]
    C0521116
    Section 6. Relevant and/or recent suicidal ideation
    Beschreibung

    Section 6. Relevant and/or recent suicidal ideation

    Alias
    UMLS CUI-1
    C0424000
    Relevant/recent suicidal ideation
    Beschreibung

    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.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0424000
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C0424000
    UMLS CUI [2,2]
    C0750502
    Section 7. Suicidal behaviour present during study
    Beschreibung

    Section 7. Suicidal behaviour present during study

    Alias
    UMLS CUI-1
    C1760428
    UMLS CUI-2
    C0347984
    UMLS CUI-3
    C2347804
    Suicidal behaviour present during study
    Beschreibung

    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

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1760428
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2347804
    Section 8. Comments on medical and psychiatric treatment
    Beschreibung

    Section 8. Comments on medical and psychiatric treatment

    Alias
    UMLS CUI-1
    C0237726
    UMLS CUI-3
    C0204523
    Comments on medical/psych treatment
    Beschreibung

    Provide any additional comments or explanation, including, but not limited to, both medical and psychiatric treatment, outcome and follow-up.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0237726
    UMLS CUI [2]
    C0204523
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Possible Suicidality-Related Adverse Event

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of Visit/Assessment
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Study site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Subject No.
    Item
    Patient No.
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Section 1
    C1508263 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    C3166387 (UMLS CUI-4)
    Possible suicidality-related AE
    Item
    Possible suicidality related AE
    text
    C0877248 (UMLS CUI [1,1])
    C2732635 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    Possible suicidality-related AE start date
    Item
    Start Date
    date
    C2697888 (UMLS CUI [1,1])
    C2732635 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    Item Group
    Section 2. Brief description of possible Suicidality-Related Adverse Event
    C0877248 (UMLS CUI-1)
    C3166387 (UMLS CUI-2)
    C0678257 (UMLS CUI-3)
    Suicidality-Related Adverse Event description
    Item
    Brief description of possible suicidality-related AE
    text
    C0877248 (UMLS CUI [1,1])
    C3166387 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    Item Group
    Section 3. Possible causes of possible suicidality-related adverse event
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    C0015127 (UMLS CUI-4)
    Possible causes of possible suicidality-related adverse event: Disease under study
    Item
    Disease under study
    boolean
    C2732635 (UMLS CUI [1,1])
    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])
    Possible causes of possible suicidality-related adverse event: Concomitant medications
    Item
    Concomitant medications
    boolean
    C2732635 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    C0015127 (UMLS CUI [1,4])
    C2347852 (UMLS CUI [2])
    Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
    Item
    Comorbid psychiatric condition(s)
    boolean
    C2732635 (UMLS CUI [1,1])
    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])
    Possible causes of possible suicidality-related adverse event: Medical condition(s)
    Item
    Medical condition(s)
    boolean
    C2732635 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    C0015127 (UMLS CUI [1,4])
    C0009488 (UMLS CUI [2])
    Possible causes of possible suicidality-related adverse event: Psycho-social stressors
    Item
    Psycho-social stressors
    boolean
    C2732635 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    C0015127 (UMLS CUI [1,4])
    C0748073 (UMLS CUI [2])
    Possible causes of possible suicidality-related adverse event: Withdrawal of investigational product(s)
    Item
    Withdrawal of investigational product(s)
    boolean
    C0877248 (UMLS CUI [1,1])
    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])
    Possible causes of possible suicidality-related adverse event: Investigational product dose change
    Item
    Investigational product dose change
    boolean
    C0877248 (UMLS CUI [1,1])
    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])
    Possible causes of possible suicidality-related adverse event: Lack of efficacy
    Item
    Lack of efficacy
    boolean
    C0877248 (UMLS CUI [1,1])
    C2732635 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    C0015127 (UMLS CUI [1,4])
    C0235828 (UMLS CUI [2])
    Possible causes of possible suicidality-related adverse event: Investigational product(s)
    Item
    Investigational product(s)
    boolean
    C0877248 (UMLS CUI [1,1])
    C2732635 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    C0015127 (UMLS CUI [1,4])
    C0304229 (UMLS CUI [2])
    Other possible causes of possible suicidality-related adverse event
    Item
    Other
    boolean
    C0205394 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2732635 (UMLS CUI [1,3])
    C3166387 (UMLS CUI [1,4])
    C0015127 (UMLS CUI [1,5])
    Specify other possible causes of possible suicidality-related adverse event
    Item
    Other, specify
    text
    C1521902 (UMLS CUI [1,1])
    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])
    Item Group
    Section 4. Provide Information
    C0748059 (UMLS CUI-1)
    History of psychiatric conditions
    Item
    Has the subject had any psychiatric conditions in the past?
    boolean
    C0455498 (UMLS CUI [1])
    Previous suicidal ideation/behaviour or self-harm
    Item
    Has the subject had any suicidal ideation, behaviour or self-harm in the past?
    boolean
    C0424000 (UMLS CUI [1,1])
    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])
    Current use of iIllicit drugs
    Item
    Subject's current use of llicit drugs?
    boolean
    C0086190 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Current alcohol consumption
    Item
    Subject's current use of alcohol?
    boolean
    C0001948 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Item
    Family history of suicidality?
    text
    C0241889 (UMLS CUI [1,1])
    C3166387 (UMLS CUI [1,2])
    Family history of suicidality
    Code List
    Family history of suicidality?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Item
    Family history of psychiatric disorders?
    text
    C0241889 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    Family history of suicidality
    Code List
    Family history of psychiatric disorders?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Item Group
    Section 5. Provide information on the subject's current psycho-social stressors
    C0748073 (UMLS CUI-1)
    Current psycho-social stressors
    Item
    Provide information on the subject's current psycho-social stressors
    text
    C0748073 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Item Group
    Section 6. Relevant and/or recent suicidal ideation
    C0424000 (UMLS CUI-1)
    Significant/recent suicidal ideation
    Item
    Relevant/recent suicidal ideation
    text
    C0424000 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C0424000 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    Item Group
    Section 7. Suicidal behaviour present during study
    C1760428 (UMLS CUI-1)
    C0347984 (UMLS CUI-2)
    C2347804 (UMLS CUI-3)
    Suicidal behaviour during study
    Item
    Suicidal behaviour present during study
    text
    C1760428 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Item Group
    Section 8. Comments on medical and psychiatric treatment
    C0237726 (UMLS CUI-1)
    C0204523 (UMLS CUI-3)
    Medical and psychiatric treatment
    Item
    Comments on medical/psych treatment
    text
    C0237726 (UMLS CUI [1])
    C0204523 (UMLS CUI [2])
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