NCT00828230

Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Randomised, Double-blind, Placebo-controlled, Multicentre, Comparative Phase II Pilot Study on the Efficacy and Tolerability of an 8-week Rectal Treatment With 2 mg Budesonide or Placebo for the Prevention of Acute Radiation Proctitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Proctitis

Interventions

Type	Name	Description
DRUG	budesonide	One application of 2mg budesonide once daily for 8 weeks
DRUG	Placebo foam	One application of placebo foam once daily for 8 weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-08-01
• Completion: 2011-10-01
• First posted: 2009-01-23
• Last updated: 2012-01-30

Locations

3 sites across 1 country: Germany