ID

32429

Description

This ODM-file contains the form to document the Randomisation number, the investigational product container number, the previous clinical trial participation, the subject recruitment and the prior participation in sumatriptan 85mg/ naproxen sodium 500mg tablet studies. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Keywords

Versions (1)
  1. 10/31/18 10/31/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 31, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

English

Subject Recruitment, Randomisation Number, Investigational Product Container Number, Previous Clinical Trial Participation, Prior participation in Sumatriptan 85mg/Naproxen Sodium 500mg Tablet Studies

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Recruitment
Description

Subject Recruitment

Alias
UMLS CUI-1
C2986327
How was the subject recruited for this study?
Description

Subject Recruitment

Data type

integer

Alias
UMLS CUI [1]
C0242800
If "The subject contacted the site in response to some other means" was checked: Specify
Description

Specification: Subject contacted the site

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0332158
UMLS CUI [1,4]
C2825164
If "The site contacted the subject through some other means" was checked: Specify
Description

Specification: The site contacted the subject

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0332158
UMLS CUI [1,4]
C0681850
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigational Product Container Number
Description

Investigational Product Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Record the identifying number from the investigational product container dispensed at this visit.
Description

Investigational Product Container Number

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Previous Clinical Trial Participation (Migraine Treatment)
Description

Previous Clinical Trial Participation (Migraine Treatment)

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0149931
UMLS CUI-3
C0087111
Did the subject participate in any other research studies of migraine treatments in the past 3 years?
Description

If Yes, record how many research studies.

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0149931
UMLS CUI [1,3]
C0087111
In case of a previous participation in any other research studies of migraine treatments in the past 3 years: Record how many research studies
Description

Number of Study Participations (Migraine Treatments)

Data type

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0149931
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0750480
Prior Participation in Sumatriptan 85mg / Naproxen Sodium 500mg Tablet Studies
Description

Prior Participation in Sumatriptan 85mg / Naproxen Sodium 500mg Tablet Studies

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0075632
UMLS CUI-3
C0027396
Did the subject participate in a previous study of sumatriptan 85mg/naproxen sodium 500mg tablets?
Description

Prior Participation in Sumatriptan 85mg / Naproxen 500mg Tablet Studies

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0075632
UMLS CUI [1,3]
C0027396
If the subject participated in a previous study of sumatriptan 85mg / naproxen sodium 500mg tablets, then complete the following: Previous Protocol Number
Description

Choose from these Protocol Numbers: MT400-104 MT400-204 MT400-301 MT400-302 MT400-303

Data type

integer

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C0205156
If the subject participated in a previous study of sumatriptan 85mg / naproxen sodium 500mg tablets, then complete the following: Previous Centre Number
Description

Previous Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
UMLS CUI [1,3]
C0205156
If the subject participated in a previous study of sumatriptan 85mg / naproxen sodium 500mg tablets, then complete the following: Previous Subject Number
Description

Previous Subject Number

Data type

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
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Similar models

Subject Recruitment, Randomisation Number, Investigational Product Container Number, Previous Clinical Trial Participation, Prior participation in Sumatriptan 85mg/Naproxen Sodium 500mg Tablet Studies

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Subject Recruitment
C2986327 (UMLS CUI-1)
Item
How was the subject recruited for this study?
integer
C0242800 (UMLS CUI [1])
Subject Recruitment
Code List
How was the subject recruited for this study?
CL Item
The subject contacted the site in response to a printed, radio, or TV advertisement (1)
CL Item
The subject contacted the site in response to a flyer (2)
CL Item
The subject contacted the site in response to word-of-mouth referral (3)
CL Item
The subject contacted the site in response to referral by another doctor outside this clinic (4)
CL Item
The subject contacted the site in response to some other means (5)
CL Item
The site contacted the subject through retrospective chart review of previous or current patients (6)
CL Item
The site contacted the subject during a visit scheduled for headache (7)
CL Item
The site contacted the subject during a visit scheduled for some other medical reason (8)
CL Item
The site contacted the subject through some other means (9)
Specification: Subject contacted the site
Item
If "The subject contacted the site in response to some other means" was checked: Specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C2825164 (UMLS CUI [1,4])
Specification: The site contacted the subject
Item
If "The site contacted the subject through some other means" was checked: Specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Record randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Investigational Product Container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational Product Container Number
Item
Record the identifying number from the investigational product container dispensed at this visit.
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Previous Clinical Trial Participation (Migraine Treatment)
C2348568 (UMLS CUI-1)
C0149931 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
Item
Did the subject participate in any other research studies of migraine treatments in the past 3 years?
text
C2348568 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Previous Clinical Trial Participation (Migraine Treatment)
Code List
Did the subject participate in any other research studies of migraine treatments in the past 3 years?
CL Item
Yes (Y)
CL Item
No (N)
Number of Study Participations (Migraine Treatments)
Item
In case of a previous participation in any other research studies of migraine treatments in the past 3 years: Record how many research studies
integer
C2348568 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Item Group
Prior Participation in Sumatriptan 85mg / Naproxen Sodium 500mg Tablet Studies
C2348568 (UMLS CUI-1)
C0075632 (UMLS CUI-2)
C0027396 (UMLS CUI-3)
Item
Did the subject participate in a previous study of sumatriptan 85mg/naproxen sodium 500mg tablets?
text
C2348568 (UMLS CUI [1,1])
C0075632 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
Prior Participation in Sumatriptan 85mg / Naproxen 500mg Tablet Studies
Code List
Did the subject participate in a previous study of sumatriptan 85mg/naproxen sodium 500mg tablets?
CL Item
Yes (Y)
CL Item
No (N)
Previous Protocol Number
Item
If the subject participated in a previous study of sumatriptan 85mg / naproxen sodium 500mg tablets, then complete the following: Previous Protocol Number
integer
C3274381 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Previous Centre Number
Item
If the subject participated in a previous study of sumatriptan 85mg / naproxen sodium 500mg tablets, then complete the following: Previous Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Previous Subject Number
Item
If the subject participated in a previous study of sumatriptan 85mg / naproxen sodium 500mg tablets, then complete the following: Previous Subject Number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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