NCT00233896 - 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)

Baehr PH, Levine DS, Bouvier ME, Hockenbery DM, Gooley TA, Stern JG, Martin PJ, McDonald GB
Oral beclomethasone dipropionate for treatment of human intestinal graft-versus-host disease. Transplantation. 1995 Dec 15;60(11):1231-8.
Hockenbery DM, Cruickshank S, Rodell TC, McDonald GB
A phase 3 randomized, placebo-controlled study of oral beclomethasone 17, 21-dipropionate (BDP) in conjunction with ten days of high-dose prednisone therapy for patients with gastrointestinal graft vs.
McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS
Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35.

A Randomized, Placebo-Controlled, Multi-Center Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal Graft Vs. Host Disease

Details for clinical trial NCT00233896

Clinical trial NCT00233896 - References