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To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Double-Blind, Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy Opf Trexima in the Acute Treatment of Migraine Headaches

NCT00433732•POZEN

View on ClinicalTrials.gov

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.

Detailed Description

The primary objective of this study is 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. Another objective of this study is to evaluate the efficacy of Trexima when compared to the individual components (sumatriptan and naproxen sodium) using sustained pain-free as the endpoint. It is the intent that this study be sufficiently powered to detect differences that are clinically meaningful and statistically significant in order to meet both objectives.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A subject will be eligible for inclusion in this study if all of the following criteria apply:
•1. Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of
•* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant): or,
•* Child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and employs one of the following acceptable measures of contraception:
•* Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 24 hours); subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for randomized treatment; or
•* Female sterilization (pregnancy test not required); or
•* Sterilization of male partner; or implants of levonorgestrel; or
•* Injectable progestogen; or
•* Oral contraceptive (combined or progestogen only); or
•* Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or
+8 more criteria

Exclusion Criteria

•A subject will not be eligible for this study if any one or more of the following criteria apply:
•1. Subject has received another investigational drug within the 4 weeks preceding this study, subject was discontinued from the MT400-303 POZEN study, or subject was enrolled in this study or the MT400-302 POZEN study previously.
•2. Subject has any concurrent medical or psychiatric condition that may affect the interpretation of efficacy and/or safety data or which otherwise contraindicates participation in a clinical trial with a new chemical entity. This includes, but is not limited to, chronic unstable debilitating diseases such as HIV infection, multiple sclerosis, cancer, etc.
•3. Subject has a clinically significant disorder that, in the opinion of the investigator, would result in the subject's inability to understand and comply with the requirements of the study.
•4. Subject has a history, signs, or symptoms of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes or other significant underlying cardiovascular disease.
•5. Subject has a history of cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram (ECG) abnormality that, in the investigator's opinion, contraindicates participation in this study.
•6. Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks.
•7. Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular disease, based on history or the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
•8. Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease, or Raynaud syndrome.
•9. Subject has uncontrolled hypertension at screening (sitting systolic pressure \>160 millimeters of mercury \[mmHg\], diastolic pressure \>95 mmHg).
+15 more criteria

Locations (2)

Little Rock Family Practice Clinic

Little Rock, Arkansas, United States

Pozen, Inc.

Chapel Hill, North Carolina, United States

Key Dates

Start Date

August 1, 2004

Completion Date

April 1, 2005

Last Updated

February 12, 2007

Enrollment

1,400

Estimated participants

Conditions

Migraine Headaches

Interventions

sumatriptan

DRUG

naproxen sodium

DRUG

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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