Clinical Trial: Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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 Preve
Brief 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.
Detailed Summary:
Sponsor: Dr. Falk Pharma GmbH
Current Primary Outcome: Proportion of patients developing radiation proctitis during treatment or need rescue medication [ Time Frame: within 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to occurrence of acute radiation proctitis [ Time Frame: During 8 weeks ]
- Time to occurrence of chronic radiation proctitis [ Time Frame: Within 1 year ]
- Adverse Events (AEs) [ Time Frame: During 8 weeks of treatment ]
Original Secondary Outcome: Same as current
Information By: Dr. Falk Pharma GmbH
Dates:
Date Received: January 22, 2009
Date Started: September 2008
Date Completion:
Last Updated: January 26, 2012
Last Verified: January 2012
