CLINICAL TRIALS PROFILE FOR NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
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All Clinical Trials for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00329355 ↗ | Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA) | Completed | GlaxoSmithKline | Phase 3 | 2006-05-01 | This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine. |
| NCT00329459 ↗ | Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea | Completed | GlaxoSmithKline | Phase 3 | 2006-05-01 | This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine. |
| NCT00382993 ↗ | A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2) | Completed | GlaxoSmithKline | Phase 3 | 2006-12-01 | This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 2 of 2] |
| NCT00383162 ↗ | A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2) | Completed | GlaxoSmithKline | Phase 3 | 2006-11-01 | This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 1 of 2] |
| NCT00387881 ↗ | TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1) | Completed | GlaxoSmithKline | Phase 3 | 2006-09-01 | 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. |
| NCT00434083 ↗ | To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches | Completed | POZEN | Phase 3 | 2004-07-01 | - to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine - to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and - to evaluate the safety of the Trexima. |
| NCT00488514 ↗ | Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents | Completed | GlaxoSmithKline | Phase 3 | 2007-07-13 | This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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