ID

38946

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 is used to calculate the subject's median habitual bedtime from their bedtime diary, to decide when the investigational product is to be taken (60 minutes before habitual bedtime). This form is filled in at least 8 days after the Screening Visit (Visit 1), and before Visit 2.

Länk

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

Nyckelord

Versioner (3)
  1. 2019-11-14 2019-11-14 -
  2. 2019-11-14 2019-11-14 -
  3. 2019-11-15 2019-11-15 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 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

Engelsk

Bedtime Diary - Worksheet for Investigators

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

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

Date of Visit/Assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Subject Bedtime Diary
Beskrivning

Subject Bedtime Diary

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0521112
Day No.
Beskrivning

Fill in itemgroup for seven days.

Datatyp

integer

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
Date
Beskrivning

Diary Entry Date

Datatyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Time (Lights-Out Last Night)
Beskrivning

The "DE:GER (Germany/German)" version of this form uses 24hr format.

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C4740612
UMLS CUI [1,3]
C0392223
UMLS CUI [1,4]
C0205156
UMLS CUI [1,5]
C0240526
AM/PM
Beskrivning

The "DE:GER (Germany/German)" version of this form uses 24hr format, and this item is not included in that form.

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0040223
Bedtimes ranked chronologically
Beskrivning

Bedtimes ranked chronologically

Alias
UMLS CUI-1
C0521112
UMLS CUI-2
C1705176
Bedtime No.
Beskrivning

Bedtime No.

Datatyp

text

Alias
UMLS CUI [1,1]
C0521112
UMLS CUI [1,2]
C0699794
Bedtime
Beskrivning

Bedtime

Datatyp

time

Alias
UMLS CUI [1]
C0521112
Median Habitual Bedtime
Beskrivning

Median Habitual Bedtime

Alias
UMLS CUI-1
C0876920
UMLS CUI-2
C0205353
UMLS CUI-3
C0521112
UMLS CUI-4
C1441506
Median Habitual Bedtime
Beskrivning

Median of odd number of bedtimes is the bedtime (non-rounded) with equal number of earlier and later times after ranking chronologically; median of even number of bedtimes is mean of 2 middle times after ranking.

Datatyp

time

Alias
UMLS CUI [1,1]
C0876920
UMLS CUI [1,2]
C0205353
UMLS CUI [1,3]
C0521112
Median Habitual Bedtime rounded to nearest quarter hour
Beskrivning

Call the subject back to schedule the date and time of their arrival at the clinic for their first PSG screening visit. Note: Subjects are to arrive at the clinic in the evening no less than 2 hours before receiving study medication, which is taken 60 minutes before the Median Habitual Bedtime (determined from the Subject Bedtime Diary calculations).

Datatyp

time

Alias
UMLS CUI [1,1]
C0876920
UMLS CUI [1,2]
C0205353
UMLS CUI [1,3]
C0521112
UMLS CUI [1,4]
C0332232
Median calculated by
Beskrivning

Print Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0876920
UMLS CUI [1,2]
C0205353
UMLS CUI [1,3]
C0521112
UMLS CUI [1,4]
C1441506
UMLS CUI [1,5]
C2826892
Signature
Beskrivning

Signature of Investigator calculating Median Habitual Bedtime

Datatyp

text

Alias
UMLS CUI [1,1]
C0876920
UMLS CUI [1,2]
C0205353
UMLS CUI [1,3]
C0521112
UMLS CUI [1,4]
C1441506
UMLS CUI [1,5]
C2346576
Date Completed
Beskrivning

Date of Median Habitual Bedtime Calculation

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0876920
UMLS CUI [1,3]
C0205353
UMLS CUI [1,4]
C0521112
UMLS CUI [1,5]
C1441506
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Similar models

Bedtime Diary - Worksheet for Investigators

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Subject Bedtime Diary
C3890583 (UMLS CUI-1)
C0521112 (UMLS CUI-2)
Item
Day No.
integer
C3890583 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Diary Entry Count
Code List
Day No.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
Diary Entry Date
Item
Date
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of lights-out previous night
Item
Time (Lights-Out Last Night)
time
C0040223 (UMLS CUI [1,1])
C4740612 (UMLS CUI [1,2])
C0392223 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
C0240526 (UMLS CUI [1,5])
Item
AM/PM
text
C1521902 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Time specification: AM/PM
Code List
AM/PM
CL Item
AM (AM)
CL Item
PM (PM)
Item Group
Bedtimes ranked chronologically
C0521112 (UMLS CUI-1)
C1705176 (UMLS CUI-2)
Item
Bedtime No.
text
C0521112 (UMLS CUI [1,1])
C0699794 (UMLS CUI [1,2])
Bedtime No.
Code List
Bedtime No.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
Bedtime
Item
Bedtime
time
C0521112 (UMLS CUI [1])
Item Group
Median Habitual Bedtime
C0876920 (UMLS CUI-1)
C0205353 (UMLS CUI-2)
C0521112 (UMLS CUI-3)
C1441506 (UMLS CUI-4)
Median Habitual Bedtime
Item
Median Habitual Bedtime
time
C0876920 (UMLS CUI [1,1])
C0205353 (UMLS CUI [1,2])
C0521112 (UMLS CUI [1,3])
Median Habitual Bedtime rounded
Item
Median Habitual Bedtime rounded to nearest quarter hour
time
C0876920 (UMLS CUI [1,1])
C0205353 (UMLS CUI [1,2])
C0521112 (UMLS CUI [1,3])
C0332232 (UMLS CUI [1,4])
Name of Investigator calculating Median Habitual Bedtime
Item
Median calculated by
text
C0876920 (UMLS CUI [1,1])
C0205353 (UMLS CUI [1,2])
C0521112 (UMLS CUI [1,3])
C1441506 (UMLS CUI [1,4])
C2826892 (UMLS CUI [1,5])
Signature of Investigator calculating Median Habitual Bedtime
Item
Signature
text
C0876920 (UMLS CUI [1,1])
C0205353 (UMLS CUI [1,2])
C0521112 (UMLS CUI [1,3])
C1441506 (UMLS CUI [1,4])
C2346576 (UMLS CUI [1,5])
Date of Median Habitual Bedtime Calculation
Item
Date Completed
date
C0011008 (UMLS CUI [1,1])
C0876920 (UMLS CUI [1,2])
C0205353 (UMLS CUI [1,3])
C0521112 (UMLS CUI [1,4])
C1441506 (UMLS CUI [1,5])
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