TREXIMA For Menstrual Migraine in Women With Dysmenorrhea - Tabular View

Tracking Information

First Received Date ^ICMJE

May 22, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Score on a migraine pain scale at 2 hours through 48 hours for a single menstrual migraine attack

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00329459 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

TREXIMA For Menstrual Migraine in Women With Dysmenorrhea

Official Title ^ICMJE

See Detailed Description

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: sumatriptan succinate/naproxen sodium

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

320

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00329459

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

TRX105850

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP