NCT00746447 - 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)

Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Bátovský M, Lozynsky YS, Zakharash Y, Rácz I, Kull K, Vcev A, Faszczyk M, Dilger K, Greinwald R, Mueller R; International Salofalk OD Study Group
Randomised clinical trial: a comparative dose

Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis

Details for clinical trial NCT00746447

Clinical trial NCT00746447 - References