Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00329355 |
Recruitment Status :
Completed
First Posted : May 24, 2006
Last Update Posted : January 23, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Migraine Disorders | Drug: sumatriptan succinate/naproxen sodium | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 351 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 Start Date : | May 2006 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | November 2006 |

- Score on a 4-pt migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ]
- 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 [ Time Frame: 2 to 48 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329355
United States, Arizona | |
GSK Investigational Site | |
Chandler, Arizona, United States, 85224 | |
United States, California | |
GSK Investigational Site | |
Irvine, California, United States, 92618 | |
GSK Investigational Site | |
Redondo Beach, California, United States, 90277 | |
GSK Investigational Site | |
San Francisco, California, United States, 94109 | |
GSK Investigational Site | |
Santa Monica, California, United States, 90404 | |
United States, Colorado | |
GSK Investigational Site | |
Boulder, Colorado, United States, 80304 | |
GSK Investigational Site | |
Colorado Springs, Colorado, United States, 80909 | |
United States, Florida | |
GSK Investigational Site | |
Port Orange, Florida, United States, 32127 | |
GSK Investigational Site | |
Sunrise, Florida, United States, 33351 | |
GSK Investigational Site | |
West Palm Beach, Florida, United States, 33407 | |
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60614 | |
United States, Indiana | |
GSK Investigational Site | |
South Bend, Indiana, United States, 46601 | |
United States, Louisiana | |
GSK Investigational Site | |
Baton Rouge, Louisiana, United States, 70808 | |
United States, Michigan | |
GSK Investigational Site | |
Ann Arbor, Michigan, United States, 48104 | |
United States, Nebraska | |
GSK Investigational Site | |
Omaha, Nebraska, United States, 68134 | |
United States, New Mexico | |
GSK Investigational Site | |
Albuquerque, New Mexico, United States, 87108 | |
United States, New York | |
GSK Investigational Site | |
New York, New York, United States, 10021 | |
GSK Investigational Site | |
New York, New York, United States, 10022 | |
United States, North Carolina | |
GSK Investigational Site | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Ohio | |
GSK Investigational Site | |
Cincinnati, Ohio, United States, 45245 | |
GSK Investigational Site | |
Cincinnati, Ohio, United States, 45267 | |
GSK Investigational Site | |
Toledo, Ohio, United States, 43614-5809 | |
GSK Investigational Site | |
West Chester, Ohio, United States, 45069 | |
United States, Oklahoma | |
GSK Investigational Site | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Oregon | |
GSK Investigational Site | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Carnegie, Pennsylvania, United States, 15106 | |
GSK Investigational Site | |
Philadelphia, Pennsylvania, United States, 19114 | |
United States, Rhode Island | |
GSK Investigational Site | |
Warwick, Rhode Island, United States, 02886 | |
United States, South Carolina | |
GSK Investigational Site | |
Mount Pleasant, South Carolina, United States, 29464 | |
United States, Tennessee | |
GSK Investigational Site | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
GSK Investigational Site | |
Georgetown, Texas, United States, 78626 | |
GSK Investigational Site | |
Houston, Texas, United States, 77054 | |
GSK Investigational Site | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
GSK Investigational Site | |
Salt Lake City, Utah, United States, 84109 | |
United States, Washington | |
GSK Investigational Site | |
Seattle, Washington, United States, 98195 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00329355 |
Other Study ID Numbers: |
TRX105852 |
First Posted: | May 24, 2006 Key Record Dates |
Last Update Posted: | January 23, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
menstrual migraine headache early intervention dysmenorrhea |
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Naproxen Sumatriptan Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |