Migraine, Without Aura Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)
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.
| Status | Completed |
| Enrollment | 679 |
| Est. completion date | February 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Albany | New York |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Alexandria | Virginia |
| United States | GSK Investigational Site | Anaheim | California |
| United States | GSK Investigational Site | Anaheim | California |
| United States | GSK Investigational Site | Anderson | South Carolina |
| United States | GSK Investigational Site | Ann Arbor | Michigan |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Bellaire | Texas |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Buena Park | California |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Diamond Bar | California |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Greensboro | North Carolina |
| United States | GSK Investigational Site | Independence | Ohio |
| United States | GSK Investigational Site | Kalamazoo | Michigan |
| United States | GSK Investigational Site | Katy | Texas |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newport Beach | California |
| United States | GSK Investigational Site | North Dartmouth | Massachusetts |
| United States | GSK Investigational Site | Pembroke Pines | Florida |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Richardson | Texas |
| United States | GSK Investigational Site | Rochester | New York |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Santa Monica | California |
| United States | GSK Investigational Site | Seattle | Washington |
| United States | GSK Investigational Site | Seattle | Washington |
| United States | GSK Investigational Site | Simpsonville | South Carolina |
| United States | GSK Investigational Site | Springfield | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis Park | Minnesota |
| United States | GSK Investigational Site | Stamford | Connecticut |
| United States | GSK Investigational Site | Valley Stream | New York |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Wenatchee | Washington |
| United States | GSK Investigational Site | West Chester | Ohio |
| United States | GSK Investigational Site | West Jordan | Utah |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | Westerville | Ohio |
| United States | GSK Investigational Site | Westlake Village | California |
| United States | GSK Investigational Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable M
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine. | 2 hours through 24 hours after Treatment | No |
| Secondary | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment. | 0.5, 1, and 4 hours after Treatment | No |
| Secondary | Sustained Headache Relief 2-24 Hours After Treatment | Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication. | 2-24 hours after treatment | No |
| Secondary | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time. | 0.5, 1, 2, and 4 hours after treatment | No |
| Secondary | Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment | Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack. | 0 - 24 hours after treatment | No |
| Secondary | Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.) | 1-2, and 2- 4 hours after treatment | No |
| Secondary | Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.) | 1-2 and 2-4 hours after treatment | No |
| Secondary | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.) | 2 and 4 hours after treatment | No |
| Secondary | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction. | 0 - 24 hours after treatment | No |