Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

Phase 3

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: sumatriptan succinate/naproxen sodium; Drug: placebo

• Registration Number: NCT00329459
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

Detailed Description

A randomized, double-blind, single migraine attack, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and tolerability of TREXIMA\* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea. (TREXIMET was formerly known as TREXIMA)

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 1	sumatriptan succinate/naproxen sodium	Treximet (sumatriptan/naproxen sodium)
arm 2	placebo	placebo to match

Primary Outcome Measures

Name	Time	Method
Score on a 4-point migraine pain scale for a single menstrual migraine attack	2 to 48 hours

Secondary Outcome Measures

Name	Time	Method
Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability	from 2 to 48 hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Wenatchee, Washington, United States