drugset / Trial / NCT00828230

Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

NCT00828230

Phase 2 Terminated 17 enrolled Dr. Falk Pharma GmbH
RandomizedParallel-groupQuadruple-blindPrevention

Summary

To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of chronic radiation proctitis 1 year after start of radiation therapy.

Timeline

Start
2008-09
Primary completion
2011-08
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 2 mg Rectal

Indications