Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents

NCT ID: NCT00488514

Last Updated: 2017-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-13
• Study Completion Date: 2009-08-20

Brief Summary

This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.

Detailed Description

This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.

Conditions

Migraine Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Drug

Combination Tablet of Treximet (sumatriptan/naproxen sodium)

Group Type: OTHER

Combination Tablet of Treximet (sumatriptan/naproxen sodium)

Intervention Type: DRUG

Combination Tablet of Treximet(sumatriptan/naproxen sodium)

Interventions

Combination Tablet of Treximet (sumatriptan/naproxen sodium)

Combination Tablet of Treximet(sumatriptan/naproxen sodium)

Intervention Type: DRUG

Other Intervention Names

Combination Product (sumatriptan succinate / naproxen sodium)

Eligibility Criteria

Inclusion Criteria

• Subject is between 12 and 17 years old at the Screening visit.
• If subject is female, she must have a negative urine pregnancy test at screening, does not plan to become pregnant during the course of the study and agrees to use an acceptable method of birth control (i.e., a method with a failure rate <1% or abstinence) if she is/becomes sexually active.
• Subject has migraine with or without aura (2004 ICHD-II criteria).
• Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours (untreated, or unsuccessfully treated).
• Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the Screening visit.
• Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
• Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches).
• Subject and subject's parent or legal guardian are willing and able to provide informed consent prior to entry into this treatment phase of the study.
• Subject and subject's parent or legal guardian are able to read and write English or Spanish.
• Subject is able to understand and complete the electronic device to report treatment information.

Exclusion Criteria

• Subject is < 75 pounds (33.3kg).
• Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches.
• Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1, section 11.1).
• Subject has uncontrolled hypertension (See Appendix 2, section 11.2) or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
• Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
• Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of the above.
• Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
• Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
• Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
• Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
• Subject has a recent history of regular use of opioids or barbiturates for treatment of his/her migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
• Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
• Subject history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
• Subject has evidence or history of any gastrointestinal surgery or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease.
• Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
• Subject has participated in an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Gilbert, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Chico, California, United States

GSK Investigational Site

Fair Oaks, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Fullerton, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Irvine, California, United States

GSK Investigational Site

La Jolla, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Northridge, California, United States

GSK Investigational Site

Redondo Beach, California, United States

GSK Investigational Site

Roseville, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Santa Monica, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

East Hartford, Connecticut, United States

GSK Investigational Site

Fairfield, Connecticut, United States

GSK Investigational Site

Loxahatchee Groves, Florida, United States

GSK Investigational Site

Naples, Florida, United States

GSK Investigational Site

Pensacola, Florida, United States

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Savannah, Georgia, United States

GSK Investigational Site

Anderson, Indiana, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Murray, Kentucky, United States

GSK Investigational Site

Ann Arbor, Michigan, United States

GSK Investigational Site

Kalamazoo, Michigan, United States

GSK Investigational Site

Paw Paw, Michigan, United States

GSK Investigational Site

Protage, Michigan, United States

GSK Investigational Site

Richland, Michigan, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

New Brunswick, New Jersey, United States

GSK Investigational Site

Ridgewood, New Jersey, United States

GSK Investigational Site

Vorhees, New Jersey, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Albany, New York, United States

GSK Investigational Site

Amherst, New York, United States

GSK Investigational Site

Endwell, New York, United States

GSK Investigational Site

Mount Vernon, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Plainview, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Williamsville, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Westerville, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Eugene, Oregon, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Greer, South Carolina, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Georgetown, Texas, United States

GSK Investigational Site

Nassau Bay, Texas, United States

GSK Investigational Site

Plano, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

Bremerton, Washington, United States

GSK Investigational Site

Wenatchee, Washington, United States

Countries

United States

References

McDonald SA, Hershey AD, Pearlman E, Lewis D, Winner PK, Rothner D, Linder SL, Runken MC, Richard NE, Derosier FJ. Long-term evaluation of sumatriptan and naproxen sodium for the acute treatment of migraine in adolescents. Headache. 2011 Oct;51(9):1374-87. doi: 10.1111/j.1526-4610.2011.01965.x. Epub 2011 Jul 28.

Reference Type: BACKGROUND

PMID: 21797863 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Informed Consent Form

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

View Document

Document Type: Dataset Specification

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

TXA107977

Identifier Type: -

Identifier Source: org_study_id