CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 56 enrolled
Drug / intervention
Sumatriptan/Naproxen Sodium +1 moredrug
Likely dose
Sumatriptan/Naproxen Sodium 85mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01090050
NCT01090050Phase 4Completed

Treximet in the Treatment of Chronic Migraine

Cady, Roger, M.D.·interventional·Posted Mar 19, 2010·Updated Jul 3, 2013

In Brief

A Phase 4 clinical trial evaluating Sumatriptan/Naproxen Sodium and Naproxen Sodium for Chronic Migraine. Completed, enrolled 56 participants across 2 sites.

Detailed Summary

This study is being conducted to evaluate the hypothesis that use of Treximet in patients with chronic migraine, when used on a short term daily basis and as rescue for break through attacks, will reduce migraine frequency and impact.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2010
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago

Interventions

Sumatriptan/Naproxen Sodiumdrug

Each tablet of Sumatriptan/Naproxen Sodium for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.

Naproxen Sodiumdrug

Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.