Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00240630

Enrollment

646

Registered

2005-10-18

Start date

2005-10-31

Completion date

2006-06-30

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine, Migraine Disorders

Keywords

acute migraine, consistency of response, satisfaction, migraine, early intervention

Brief summary

The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.

Interventions

DRUGsumatriptan succinate/naproxen sodium

Combination Tablet of Treximet

DRUGplacebo

placebo to match

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month. * Typically experiences moderate to severe migraine pain preceded by a mild pain phase. * Differentiate between mild migraine pain and other headache types. * Women of childbearing potential must be on adequate contraception.

Exclusion criteria

* Pregnant and/or nursing mother. * History of cardiovascular disease. * Uncontrolled hypertension. * Basilar or Hemiplegic migraine. * History of stroke or transient ischemic attacks (TIA). * History of epilepsy or treated with anti-epileptics within past 5 years. * Impaired hepatic or renal function. * History of gastrointestinal bleeding or ulceration. * Allergy or hypersensitivity to Aspirin or any other NSAID. * Allergy or hypersensitivity to triptans. * Participated in an investigational drug trial in the previous 4 weeks.

Design outcomes

Primary

Measure	Time frame
Score on a migraine pain scale for multiple migraine attacks	2 to 24 hours

Secondary

Measure	Time frame
Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability	2 to 24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026