Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

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

Outcome

Outcome not reported

Stopped (Enrollment): “Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.”

Drugs

Indications