Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

January 26, 2012 updated by: Dr. Falk Pharma GmbH

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Braunschweig, Germany, 38114
        • Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig
      • Karlsruhe, Germany, 76135
        • Strahlentherapie, St. Vincentius-Kliniken gAG
      • Trier, Germany, 54290
        • Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Signed informed consent,
  • Men aged at least 18 years,
  • Patients with ECOG performance status <= 2 or Karnofsky Performance Status Scale >= 70%,
  • Estimated life expectancy more than 3 years,
  • Diagnosis of prostate carcinoma,
  • Indication for local RT in patients with prostatic cancer.

Exclusion Criteria:

  • Crohn's disease, indeterminate colitis, ulcerative colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
  • Severe or symptomatic ischaemic colitis at baseline,
  • Grade III internal haemorrhoids at baseline,
  • High risk patients needing extended radiation therapy,
  • Acute EORTC/RTOG lower GI toxicity score of >=1 at baseline,
  • Bacterial, amoebic, fungal, or viral infections of the gut,
  • Tuberculosis, hypertension, infection, diabetes mellitus (included familiarly predisposition), active peptic ulcer, osteoporosis, glaucoma, or cataract, if careful medical monitoring is not ensured,
  • Portal hypertension or liver cirrhosis,
  • Abnormal hepatic function (ALT, AST or AP > 2.5 x ULN),
  • Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drug,
  • Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
2mg rectal budesonide per day for 8 weeks
Drug: budesonide
One application of 2mg budesonide once daily for 8 weeks
Other Names:
  • Budenofalk rectal foam
Placebo Comparator: 2
One application of placebo foam once daily for 8 weeks
Drug: Placebo foam
One application of placebo foam once daily for 8 weeks
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients developing radiation proctitis during treatment or need rescue medication
Time Frame: within 8 weeks
within 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to occurrence of acute radiation proctitis
Time Frame: During 8 weeks
During 8 weeks
Time to occurrence of chronic radiation proctitis
Time Frame: Within 1 year
Within 1 year
Adverse Events (AEs)
Time Frame: During 8 weeks of treatment
During 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Study Director: Ralph Mueller, Dr, Dr. Falk Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUF-17/RAP
  • EudraCT No.: 2007-002082-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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