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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00828230
• Other study ID #: BUF-17/RAP
• Secondary ID: EudraCT No.: 200
• Status: Terminated
• Phase: Phase 2
• First received: January 22, 2009
• Last updated: January 26, 2012
• Start date: September 2008
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 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

• Proctitis
• Radiation Proctitis

Intervention

Drug:
• budesonide
One application of 2mg budesonide once daily for 8 weeks
• Placebo foam
One application of placebo foam once daily for 8 weeks

Locations

Country	Name	City	State
Germany	Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig	Braunschweig
Germany	Strahlentherapie, St. Vincentius-Kliniken gAG	Karlsruhe
Germany	Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen	Trier

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients developing radiation proctitis during treatment or need rescue medication		within 8 weeks	No
Secondary	Time to occurrence of acute radiation proctitis		During 8 weeks	No
Secondary	Time to occurrence of chronic radiation proctitis		Within 1 year	No
Secondary	Adverse Events (AEs)		During 8 weeks of treatment	Yes