Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

NCT ID: NCT00828230

Last Updated: 2012-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-10-31

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.

Conditions

Radiation Proctitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

2mg rectal budesonide per day for 8 weeks

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

One application of 2mg budesonide once daily for 8 weeks

2

One application of placebo foam once daily for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo foam

Intervention Type: DRUG

One application of placebo foam once daily for 8 weeks

Interventions

budesonide

One application of 2mg budesonide once daily for 8 weeks

Intervention Type: DRUG

Placebo foam

One application of placebo foam once daily for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Budenofalk rectal foam; placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Mueller, Dr

Role: STUDY_DIRECTOR

Dr. Falk Pharma GmbH

Locations

Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig

Braunschweig, , Germany

Strahlentherapie, St. Vincentius-Kliniken gAG

Karlsruhe, , Germany

Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen

Trier, , Germany

Countries

Germany

Other Identifiers

EudraCT No.: 2007-002082-13

Identifier Type: -

Identifier Source: secondary_id

BUF-17/RAP

Identifier Type: -

Identifier Source: org_study_id