To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
NCT00433732 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400
Last updated 2007-02-12
Summary
To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints.
Conditions
- Migraine Headaches
Interventions
- DRUG
-
sumatriptan
- DRUG
-
naproxen sodium
Sponsors & Collaborators
-
POZEN
lead INDUSTRY
Principal Investigators
-
David Taylor · POZEN
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-08-31
- Completion
- 2005-04-30
Countries
- United States
Study Locations
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