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

Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Sponsors

Lead sponsor: Dr. Falk Pharma GmbH

Source Dr. Falk Pharma GmbH
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.

Overall Status Terminated
Start Date September 2008
Completion Date October 2011
Primary Completion Date August 2011
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of patients developing radiation proctitis during treatment or need rescue medication within 8 weeks
Secondary Outcome
Measure Time Frame
Time to occurrence of acute radiation proctitis During 8 weeks
Time to occurrence of chronic radiation proctitis Within 1 year
Adverse Events (AEs) During 8 weeks of treatment
Enrollment 17
Condition
Intervention

Intervention type: Drug

Intervention name: budesonide

Description: One application of 2mg budesonide once daily for 8 weeks

Arm group label: 1

Other name: Budenofalk rectal foam

Intervention type: Drug

Intervention name: Placebo foam

Description: One application of placebo foam once daily for 8 weeks

Arm group label: 2

Other name: 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ralph Mueller, Dr Study Director Dr. Falk Pharma GmbH
Location
facility
Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig | Braunschweig, 38114, Germany
Strahlentherapie, St. Vincentius-Kliniken gAG | Karlsruhe, 76135, Germany
Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen | Trier, 54290, Germany
Location Countries

Germany

Verification Date

January 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Experimental

Description: 2mg rectal budesonide per day for 8 weeks

Arm group label: 2

Arm group type: Placebo Comparator

Description: One application of placebo foam once daily for 8 weeks

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov