Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Radiation Proctitis Clinical Trial

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 Prevention of Acute Radiation Proctitis

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00828230
Study type	Interventional
Source	Dr. Falk Pharma GmbH
Contact
Status	Terminated
Phase	Phase 2
Start date	September 2008
Completion date	October 2011

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT00756197` - CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis	Phase 4
Not yet recruiting	`NCT06087718` - Feasibility of the Maastro Applicator in Rectal Cancer	N/A
Recruiting	`NCT05489107` - New Local Treatment of Radiation-induced Proctitis
Completed	`NCT01901042` - Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms	Phase 2/Phase 3
Recruiting	`NCT01414517` - Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.	Phase 3
Recruiting	`NCT05406882` - The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis	Phase 2/Phase 3