NCT01950507 - 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)

Andree H, Hilgendorf I, Leithaeuser M, Junghanss C, Holzhueter S, Loddenkemper C, Steiner B, Freund M, Wolff D
Enteral budesonide in treatment for mild and moderate gastrointestinal chronic GVHD. Bone Marrow Transplant. 2008 Oct;42(8):541-6. doi: 10.1038/bmt.2008.209. Epub 2008 Jul 21.
Ibrahim RB, Abidi MH, Cronin SM, Lum LG, Al-Kadhimi Z, Ratanatharathorn V, Uberti JP
Nonabsorbable corticosteroids use in the treatment of gastrointestinal graft-versus-host disease. Biol Blood Marrow Transplant. 2009 Apr;15(4):395-405. doi: 10.1016/j.bbmt.2008.12.487. Epub 2009 Feb 10. Review.
Ross WA, Couriel D
Colonic graft-versus-host disease. Curr Opin Gastroenterol. 2005 Jan;21(1):64-9. Review.

Evaluation of Serum Concentrations of Budesonide in Patients Treated for Gastrointestinal Graft-Versus-Host Disease and the Potential Interaction With Fluconazole or Voriconazole

Details for clinical trial NCT01950507

Clinical trial NCT01950507 - References