ID

34747

Descripción

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 study participation status. It should be filled out at the screening visit.

Palabras clave

Versiones (3)
  1. 18/1/19 18/1/19 -
  2. 23/1/19 23/1/19 -
  3. 26/1/19 26/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de enero de 2019

DOI

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Licencia

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

Inglés

Study Participation Status

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Randomisation Number
Descripción

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Randomisation Number
Descripción

Record randomisation number.

Tipo de datos

integer

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

Investigational Product Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational Product Container Number
Descripción

Record the identifying number from the investigational product container dispensed at this visit.

Tipo de datos

integer

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

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?
Descripción

Previous Clinical Trial Participation (Migraine Treatment)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0149931
UMLS CUI [1,3]
C0087111
If Yes, record how many research studies.
Descripción

Number of Research Studies

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1265611
PRIOR PARTICIPATION IN SUMATRIPTAN 85MG / NAPROXEN SODIUM 500MG TABLET STUDIES
Descripción

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?
Descripción

Previous Study Participation of Sumatriptan/Naproxen

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0075632
UMLS CUI [1,3]
C0027396
Previous Administrative Data
Descripción

Previous Administrative Data

Alias
UMLS CUI-1
C1320722
UMLS CUI-2
C0205156
Study Number
Descripción

Study Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0600091
Previous Protocol Number
Descripción

Previous Protocol Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C0205156
Previous Centre Number
Descripción

Previous Centre Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
UMLS CUI [1,3]
C0205156
Previous Subject Number
Descripción

Previous Subject Number

Tipo de datos

integer

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

Study Participation Status

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
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
Investigational Product Container Number
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 Research Studies
Item
If Yes, record how many research studies.
integer
C2348568 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
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])
Previous Study Participation of Sumatriptan/Naproxen
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)
Item Group
Previous Administrative Data
C1320722 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
Item
Study Number
integer
C0008976 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Study Number
Code List
Study Number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Previous Protocol Number
text
C3274381 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Previous Protocol Number
Code List
Previous Protocol Number
CL Item
MT400-104 (MT400-104)
CL Item
MT400-204 (MT400-204)
CL Item
MT400-301 (MT400-301)
CL Item
MT400-302 (MT400-302)
CL Item
MT400-303 (MT400-303)
Previous Centre Number
Item
Previous Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Previous Subject Number
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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