ID

34718

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 concomitant medication. Check that either ’Yes’ or ’No’ box at the top of the page has been completed. • Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred). • Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. • It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. • It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit. • Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. • It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’. • Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: • Medical Conditions • Non-Serious Adverse Events • Serious Adverse Events Form

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1. 1/24/19 1/24/19 -
2. 1/24/19 1/24/19 -

Copyright Holder

GlaxoSmithKline

Uploaded on

January 24, 2019

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