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"Completeness of Response" Following Treatment With Treximet™ for Migraine

NCT00893737 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2011-01-25

Study results available
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Summary

Many clinical trials may not fully explore criteria that are important to some migraine patients' definition of "complete response." This study offers the opportunity to evaluate the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2 visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2 considering their study medication (Treximet™).

Conditions

Interventions

DRUG

sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)

Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.

Sponsors & Collaborators

Principal Investigators

  • Roger K Cady, MD · Clinvest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00893737 on ClinicalTrials.gov