Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

NCT00828230 — Phase 2, Terminated, 17 participants, Dr. Falk Pharma GmbH

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT00828230
Status	Terminated - Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	17 (Actual)
Sponsor	Dr. Falk Pharma GmbH (Industry)
Conditions	Radiation Proctitis
Interventions	budesonide, Placebo foam (Drug)
Dates	start 2008-09-01, primary completion 2011-08-01, completion 2011-10-01, first posted 2009-01-23, last updated 2012-01-30
Locations	3 sites in Germany

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: budesonide	2mg rectal budesonide per day for 8 weeks
2	Placebo comparator	Drug: Placebo foam	One application of placebo foam once daily for 8 weeks

budesonide (Drug), also known as Budenofalk rectal foam: One application of 2mg budesonide once daily for 8 weeks
Placebo foam (Drug), also known as placebo: One application of placebo foam once daily for 8 weeks

+Outcome measures

Primary outcomes

Proportion of patients developing radiation proctitis during treatment or need rescue medication [within 8 weeks]

Secondary outcomes

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]

+Eligibility

Sex: Male, ages: 18 Years to any

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

+Locations (3)

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

+Investigators

Ralph Mueller, Dr, Study director, Dr. Falk Pharma GmbH