ID

38902

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 contains the Study Conclusion, information on the treatment blind and whether a pregnancy has occured during the study. This form is to be completed at the Day 14 Follow-up or if the participant has/was withdrawn from the trial.

Link

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

Keywords

Versions (2)
  1. 11/12/19 11/12/19 -
  2. 11/12/19 11/12/19 - Sarah Riepenhausen
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

English

Study Conclusion, Pregnancy, Treatment Blind

1 forms  
Administrative Data
Description

Administrative Data

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

Date of Visit/Assessment

Data type

date

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

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of last contact
Description

If the subject completed the study: Date of last contact must match the last scheduled study visit date. If the subject withdrew: Date of decision to withdraw must match the date of decision to withdraw the subject from the study before normal completion. Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

If yes, complete details

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Description

if applicable

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Description

Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. If Investigator discretion, specify in next question. Select this reason if none of the other primary reasons are appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Investigator discretion, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
Case book ready for signature
Description

Data owner should check the box when data cleaning is complete

Data type

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
Office Use 1
Description

Office Use 1

Data type

boolean

Alias
UMLS CUI [1]
C0442603
Office Use 2
Description

Office Use 2

Data type

integer

Alias
UMLS CUI [1]
C0442603
Pregnancy Information (female)
Description

Pregnancy Information (female)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C0086287
Did the subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form

Data type

boolean

Alias
UMLS CUI [1]
C3828490
Pregnancy Information (male)
Description

Pregnancy Information (male)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C0086582
Did a female partner of the male subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form Check "Not Applicable" if female partner not of childbearing potential or no female partner.

Data type

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Description

If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate, and fill in the rest of this itemgroup.

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Date/time blind broken
Description

if applicable

Data type

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Description

if applicable If other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
Specification of reason treatment blind broken
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3897431
UMLS CUI [1,3]
C2348235
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Similar models

Study Conclusion, Pregnancy, Treatment Blind

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Subject withdrawn
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Withdrawal decision date
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
primary withdrawal reason
Code List
Primary reason for withdrawal
CL Item
Adverse Event (Adverse Event)
CL Item
Lack of efficacy (Lack of efficacy)
CL Item
Protocol deviation (Protocol deviation)
CL Item
Study closed/terminated (Study closed/terminated)
CL Item
Lost to Follow-up (Lost to Follow-up)
CL Item
Investigator discretion, specify (Investigator discretion, specify)
CL Item
Withdrew consent (Withdrew consent)
Specification investigator discretion
Item
Investigator discretion, specify
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Case book ready for signature
Item
Case book ready for signature
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Office Use 1
Item
Office Use 1
boolean
C0442603 (UMLS CUI [1])
Item
Office Use 2
integer
C0442603 (UMLS CUI [1])
Office Use 2
Code List
Office Use 2
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)
CL Item
8 (8)
CL Item
9 (9)
Item Group
Pregnancy Information (female)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0086287 (UMLS CUI-3)
Subject became pregnant during study
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
Pregnancy Information (male)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0086582 (UMLS CUI-3)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
partner became pregnant during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Not Applicable (Not Applicable)
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Treatment blind broken
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date/time blind broken
Item
Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (Medical emergency requiring identification of investigational product for further treatment)
CL Item
Other, specify (Other, specify)
Specification of reason treatment blind broken
Item
Specification of reason treatment blind broken
text
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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