Phase 3 N=679 Randomized Double-blind Treatment

TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

Migraine, Without Aura

Bottom Line

View on ClinicalTrials.gov: NCT00387881 ↗

Enrolled (actual)

679

Serious AEs

0.0%

Results posted

Jul 2009

Primary outcome: Primary: Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. — 25; 64; 20; 54 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: sumatriptan succinate / naproxen sodium (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.	25; 64; 20; 54	<0.001 sig
SECONDARY Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment	60; 105; 16; 23; 6; 5	—
SECONDARY Sustained Headache Relief 2-24 Hours After Treatment	77; 110	—
SECONDARY Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment	108; 153; 113; 124; 73; 85	—
SECONDARY Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment	101; 61	—
SECONDARY Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment	92; 118; 67; 84	—
SECONDARY Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours	22; 61; 11; 23	—
SECONDARY Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment	93; 63; 68; 59; 88; 49	—
SECONDARY Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score	53; 67; 56; 70; 84; 88	—

Summary

This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

Eligibility Criteria

Inclusion Criteria

At least a 6 month history of probably migraine (6 migraine attacks per month)
Males and women of childbearing potential on a adequate contraception.

Exclusion Criteria

Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
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 the 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00387881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.