Trials / Completed
CompletedNCT00387881
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 679 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sumatriptan succinate / naproxen sodium | sumatriptan 85mg / naproxen sodium 500mg |
| DRUG | Placebo | Placebo to match Treximet tablets |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2006-10-13
- Last updated
- 2016-12-16
- Results posted
- 2009-07-10
Locations
70 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00387881. Inclusion in this directory is not an endorsement.