MedTrace Logo

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

NCT00434083 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2007-02-12

No results posted yet for this study

Summary

* to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine
* to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and
* to evaluate the safety of the Trexima.

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
2004-07-31
Completion
2005-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00434083 on ClinicalTrials.gov