NCT00387881 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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

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)

Details for clinical trial NCT00387881

Clinical trial NCT00387881 - References