ID

38895

Descrizione

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 to be filled in (repeatedly, if necessary) during the study and/or at the end of the study in case of non-serious adverse events.

collegamento

https://clinicaltrials.gov/ct2/show/NCT00992160

Keywords

versioni (1)
  1. 12/11/19 12/11/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

12 novembre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Non-serious AE

1 moduli  
  1. StudyEvent: ODM
    1. Non-serious AE
Administrative data
Descrizione

Administrative data

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

Date of Visit/Assessment

Tipo di dati

date

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

Study site

Tipo di dati

text

Alias
UMLS CUI [1]
C2825164
Patient
Descrizione

Patient

Tipo di dati

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Descrizione

Subject No.

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Non-serious adverse event
Descrizione

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Sequence Number
Descrizione

Non-serious AE Sequence Number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Descrizione

Diagnosis or Sign/Symptom

Tipo di dati

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C3540840
Modified Reported Term
Descrizione

Adverse Event Modified Reported Term

Tipo di dati

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Descrizione

Hidden

Tipo di dati

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Descrizione

Hidden

Tipo di dati

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Descrizione

Failed coding

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date and Time
Descrizione

Start Date/Time

Tipo di dati

datetime

Alias
UMLS CUI [1]
C2826806
Outcome
Descrizione

if Recovered/Resolved (with or without sequelae) provide End Date and Time

Tipo di dati

text

Alias
UMLS CUI [1]
C1705586
End Date and Time
Descrizione

if applicable

Tipo di dati

datetime

Alias
UMLS CUI [1]
C2826793
Frequency
Descrizione

Non-serious adverse event frequency

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Maximum Intensity
Descrizione

Adverse Event Maximum Intensity

Tipo di dati

text

Alias
UMLS CUI [1]
C1710066
Maximum Grade
Descrizione

Adverse Event Maximum Grade

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Maximum Grade or Intensity
Descrizione

Adverse Event Maximum Grade or Intensity

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Descrizione

Action regarding Investigational Product because of non-serious adverse event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Did the subject withdraw from study as a result of this AE?
Descrizione

Subject withdrawal because of NSAE

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
Descrizione

AE possibly caused by investigational product

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Duration of AE if < 24 hours
Descrizione

Duration of AE

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Descrizione

Interval between Last Dose and AE Onset

Tipo di dati

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]
C1518404
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Similar models

Non-serious AE

1 moduli
  1. StudyEvent: ODM
    1. Non-serious AE
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Non-serious adverse event
C1518404 (UMLS CUI-1)
Non-serious AE Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Diagnosis or Sign/Symptom
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1])
C3540840 (UMLS CUI [2])
Adverse Event Modified Reported Term
Item
Modified Reported Term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start Date/Time
Item
Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
End Date/Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Frequency
text
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single Episode (Single Episode)
CL Item
Intermittent (Intermittent)
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Maximum Grade
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (Grade 1)
CL Item
Grade 2 (Grade 2)
CL Item
Grade 3 (Grade 3)
CL Item
Grade 4 (Grade 4)
Item
Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1518404 (UMLS CUI [2,2])
Maximum Grade
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (Mild or Grade 1)
CL Item
Moderate or Grade 2 (Moderate or Grade 2)
CL Item
Severe or Grade 3 (Severe or Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Action regarding Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Subject withdrawal because of NSAE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
AE possibly caused by investigational product
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
CL Item
Yes (Yes)
CL Item
No (No)
Duration of AE
Item
Duration of AE if < 24 hours
time
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Interval between Last Dose and AE Onset
Item
Time to Onset Since Last Dose
time
C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
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