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
- Conditions
- prevention of acute radiation proctitisMedDRA version: 9.1Level: LLTClassification code 10037766Term: Radiation proctitis
- Registration Number
- EUCTR2007-002082-13-DE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
1.Signed informed consent,
2.Men aged at least 18 years,
3.Patients with ECOG performance status = 2 or Karnofsky Performance Status Scale = 70%,
4.Estimated life expectancy more than 3 years,
5.Diagnosis of prostate carcinoma,
6.Indication for local RT in patients with prostatic cancer.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Crohn's disease, indeterminate colitis, ulcerative colitis, microscopic colitis (i.e., collageneous colitis and lymphocytic colitis),
2.Severe or symptomatic ischaemic colitis at baseline,
3.Grade III internal haemorrhoids at baseline,
4.High risk patients needing extended radiation therapy,
5.Acute EORTC/RTOG lower GI toxicity score of = 1 at baseline,
6.Bacterial, amoebic, fungal, or viral infections of the gut,
7.Tuberculosis, hypertension, infection, diabetes mellitus (included familiarly predisposition), active peptic ulcer, osteoporosis, glaucoma, or cataract, if careful medical monitoring is not ensured,
8.Portal hypertension or liver cirrhosis,
9.Abnormal hepatic function (ALT, AST or AP > 2.5 x ULN),
10.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,
11.Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: - To evaluate the occurrence of acute radiation proctitis (RAP) 6 weeks after end of radiotherapy (RT)<br>- To evaluate the occurrence of chronic RAP 1 year after start of RT<br>- To study safety and tolerability in the form of adverse events and laboratory parameters<br>- To assess patients' quality of life;Primary end point(s): Proportion of patients developing an acute EORTC/RTOG lower GI toxicity score = 1 on at least 2 consecutive days during treatment, or need rescue medication
- Secondary Outcome Measures
Name Time Method