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Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

NCT00828230 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2012-01-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Ralph Mueller, Dr · Dr. Falk Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00828230 on ClinicalTrials.gov