| October 11, 2006 |
| August 5, 2009 |
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| Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. [ Time Frame: 2 hours through 24 hours after Treatment ] [ Designated as safety issue: No ] |
| Score on a migraine pain scale at 2 hours through 24 hours for a single probable migraine attack. |
| Complete list of historical versions of study NCT00387881 on ClinicalTrials.gov Archive Site |
- Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment [ Time Frame: 0.5, 1, and 4 hours after Treatment ] [ Designated as safety issue: No ]
- Sustained Headache Relief 2-24 Hours After Treatment [ Time Frame: 2-24 hours after treatment ] [ Designated as safety issue: No ]
- Headache Relief Over Time Intervals of 4, 2, 1 and 0.5 Hours After Treatment [ Time Frame: 0.5, 1, 2, and 4 hours after treatment ] [ Designated as safety issue: No ]
- Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment [ Time Frame: 0 - 24 hours after treatment ] [ Designated as safety issue: No ]
- Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment [ Time Frame: 1-2, and 2- 4 hours after treatment ] [ Designated as safety issue: No ]
- Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours [ Time Frame: 1-2 and 2-4 hours after treatment ] [ Designated as safety issue: No ]
- Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment [ Time Frame: 2 and 4 hours after treatment ] [ Designated as safety issue: No ]
- Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score [ Time Frame: 0 - 24 hours after treatment ] [ Designated as safety issue: No ]
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| Freedom from all migraine pain and symptoms, satisfaction, recurrence of head pain, safety and tolerability. |
| |
| TREXIMA (Currently Treximet) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1) |
| A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA(tm) (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) |
This study was designed to determine the efficacy and tolerability of TREXIMA compared to placebo for the acute treatment of probable migraine, a sub-type of migraine. |
Phase 3 Inverventional |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Migraine Disorders |
| Drug: sumatriptan succinate / naproxen sodium |
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| Completed |
| 679 |
|
|
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.
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00387881 |
|
| TXA107563 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| August 2009 |
