ID

34734

Description

Study ID: 101998 Clinical Study ID: 101998 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 The purpose of this form is to document the subjects intake of the investigational product and the status of treatment blind. It should be filled out at the final visit.

Keywords

Versions (2)
  1. 1/23/19 1/23/19 -
  2. 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 25, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

English

Investigational Product Use/Status of Treatment Blind

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Investigational Product Use
Description

Investigational Product Use

Alias
UMLS CUI-1
C0304229
Investigational Product Use
Description

Investigational Product Use

Data type

text

Alias
UMLS CUI [1]
C0304229
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 following and Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate

Data type

text

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0449438
Date Blind Broken
Description

If Treatment blind was broken

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason Blind Broken
Description

If treatment blind was broken, Tick one

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other, specify
Description

If treatment blind was broken

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
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Similar models

Investigational Product Use/Status of Treatment Blind

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Investigational Product Use
C0304229 (UMLS CUI-1)
Item
Investigational Product Use
text
C0304229 (UMLS CUI [1])
Investigational Product Use
Code List
Investigational Product Use
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Status Of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Status of Treatmet Blind
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date Blind Broken
Item
Date Blind Broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason Blind Broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason Blind Broken
Code List
Reason Blind Broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Other Specification
Item
If other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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