ID

34511

Beschreibung

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.

Stichworte

Versionen (3)
  1. 2019-01-18 2019-01-18 -
  2. 2019-01-23 2019-01-23 -
  3. 2019-01-26 2019-01-26 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

18 januari 2019

DOI

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Lizenz

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

Englisch

Study Participation Status

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Randomisation Number
Beschreibung

Randomisation Number

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

Record randomisation number.

Datentyp

integer

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

Investigational Product Container Number

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

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0449788
Previous Clinical Trial Participation (Migraine Treatment)
Beschreibung

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?
Beschreibung

Previous Clinical Trial Participation (Migraine Treatment)

Datentyp

text

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

Number of Research Studies

Datentyp

integer

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

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?
Beschreibung

Previous Study Participation of Sumatriptan/Naproxen

Datentyp

text

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

Previous Administrative Data

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

Study Number

Datentyp

integer

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

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

Datentyp

integer

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

Previous Centre Number

Datentyp

integer

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

Previous Subject Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
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Ähnliche Modelle

Study Participation Status

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
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])
C0075632 (UMLS CUI [2])
C0027396 (UMLS CUI [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)
Previous Protocol Number
Item
Previous Protocol Number
integer
C3274381 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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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