Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

This study has been terminated.
(Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.)
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00828230
First received: January 22, 2009
Last updated: January 26, 2012
Last verified: January 2012

January 22, 2009
January 26, 2012
September 2008
August 2011   (final data collection date for primary outcome measure)
Proportion of patients developing radiation proctitis during treatment or need rescue medication [ Time Frame: within 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00828230 on ClinicalTrials.gov Archive Site
  • Time to occurrence of acute radiation proctitis [ Time Frame: During 8 weeks ] [ Designated as safety issue: No ]
  • Time to occurrence of chronic radiation proctitis [ Time Frame: Within 1 year ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) [ Time Frame: During 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Radiation Proctitis
  • Drug: budesonide
    One application of 2mg budesonide once daily for 8 weeks
    Other Name: Budenofalk rectal foam
  • Drug: Placebo foam
    One application of placebo foam once daily for 8 weeks
    Other Name: placebo
  • Experimental: 1
    2mg rectal budesonide per day for 8 weeks
    Intervention: Drug: budesonide
  • Placebo Comparator: 2
    One application of placebo foam once daily for 8 weeks
    Intervention: Drug: Placebo foam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
October 2011
August 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00828230
BUF-17/RAP, EudraCT No.: 2007-002082-13
No
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Study Director: Ralph Mueller, Dr Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP