ID

34745

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 This form contains the conclusion of the study it should be filled out at the final visit.

Keywords

Versions (2)
  1. 1/26/19 1/26/19 -
  2. 2/1/19 2/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 26, 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

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of subject completion or withdrawal
Description

Date of Completion or Withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0422727
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Was the subject withdrawn from the study?
Description

If Yes, tick the primary reason for withdrawal

Data type

text

Alias
UMLS CUI [1]
C0422727
If Yes, tick the primary reason for withdrawal:
Description

Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. If subject did not meet treatment eligibility criteria, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked.

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Other, specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2349954
UMLS CUI [2,2]
C0392360
UMLS CUI [2,3]
C0008976
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF Page Number if Applicable
Description

CRF Page Number

Data type

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Description

Only use this form to record explanatory information on anomalies such as missing data, sponsor waiver of inclusion/exclusion criteria, departures from planned investigational product administration or missed visits.

Data type

text

Alias
UMLS CUI [1]
C0947611
Signature
Description

Signature

Alias
UMLS CUI-1
C1519316
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Description

The Investigator is accountable for CRF data. However, the Principal Investigator may delegate CRF signature authority to a medically qualified Sub-investigator (as indicated on the Site Staff Signature Sheet).

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator's Name (print)
Description

Investigator's Name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
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])
Date of Completion or Withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Subject Withdrawal
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, tick the primary reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for Withdrawal
Code List
If Yes, tick the primary reason for withdrawal:
CL Item
Adverse event (Adverse event)
CL Item
Lost to follow-up (Lost to follow-up)
CL Item
Protocol violation (Protocol violation)
CL Item
Subject decided to withdraw from the study (Subject decided to withdraw from the study)
CL Item
Sponsor terminated study (Sponsor terminated study)
CL Item
Subject did not have opportunity to treat migraine (Subject did not have opportunity to treat migraine)
CL Item
Did not meet treatment eligibility criteria (Did not meet treatment eligibility criteria)
CL Item
Clinically significant screening lab values (Clinically significant screening lab values)
CL Item
Clinically significant screening ECG abnormalities (Clinically significant screening ECG abnormalities)
CL Item
Other (Other)
Other Specification
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF Page Number
Item
CRF Page Number if Applicable
text
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Signature
C1519316 (UMLS CUI-1)
Investigator's Signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Name (print)
text
C2826892 (UMLS CUI [1])
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