Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis - Full Text View

Sponsor:	Dr. Falk Pharma GmbH
Information provided by:	Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00828230

Purpose

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.

Condition	Intervention	Phase
Radiation Proctitis	Drug: budesonide Drug: Placebo foam	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:

Proportion of patients developing radiation proctitis during treatment or need rescue medication [ Time Frame: within 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	32
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2mg rectal budesonide per day for 8 weeks	Drug: budesonide One application of 2mg budesonide once daily for 8 weeks
2: Placebo Comparator One application of placebo foam once daily for 8 weeks	Drug: Placebo foam One application of placebo foam once daily for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828230

Contacts

Contact: Wolfgang Hoffmann, Prof Dr med	++49-(0)531-595-3371	w.hoffmann@klinikum-braunschweig.de
Contact: Max Reinshagen, Prof Dr med	++49-(0)531-595-2431	m.reinshagen@klinikum-braunschweig.de

Locations

Germany
Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig	Recruiting
Braunschweig, Germany, 38114
Contact: Wolfgang Hoffmann, Prof. Dr. med. ++49-(0)531-595-3371 w.hoffmann@klinikum-braunschweig.de
Contact: Martina Becker-Schiebe, PD Dr. med. ++49-(0)531 595 3323 m.schiebe@klinikum-braunschweig.de
Principal Investigator: Wolfgang Hoffmann, Prof Dr med
Sub-Investigator: Martina Becker-Schiebe, PD Dr med
Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen	Recruiting
Trier, Germany, 54290
Contact: Wolfgang Dornoff, Dr. med. +49-651-947-2350 dornoff@mutterhaus.de
Principal Investigator: Wolfgang Dornoff, Dr. med.
Strahlentherapie, St. Vincentius-Kliniken gAG	Recruiting
Karlsruhe, Germany, 76135
Contact: Johannes Claßen, PD Dr. med. +49-721-8108-5151 johannes.classen@vincentius-ka.de
Principal Investigator: Johannes Claßen, PD Dr. med.

Sponsors and Collaborators

Dr. Falk Pharma GmbH

Investigators

Study Director:

Ralph Mueller, Dr

Dr. Falk Pharma GmbH

More Information

No publications provided

Responsible Party:	Dr. Falk Pharma GmbH ( Dr Ralph Mueller - Project Manager Clinical Research & Development )
Study ID Numbers:	BUF-17/RAP, EudraCT No.: 2007-002082-13
Study First Received:	January 22, 2009
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00828230 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:

budesonide
placebo
acute radiation proctitis

late radiation proctitis
Prevention of acute radiation proctitis
Prevention of late radiation proctitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Intestinal Diseases
Hormones
Glucocorticoids

Rectal Diseases
Pharmacologic Actions
Digestive System Diseases
Autonomic Agents
Therapeutic Uses
Proctitis
Peripheral Nervous System Agents
Gastroenteritis
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010