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:
Dr. Falk Pharma GmbH
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
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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:
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 ]
| Enrollment: | 17 |
| Study Start Date: | September 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
2mg rectal budesonide per day for 8 weeks
|
Drug: budesonide
One application of 2mg budesonide once daily for 8 weeks
Other Name: Budenofalk rectal foam
|
|
Placebo Comparator: 2
One application of placebo foam once daily for 8 weeks
|
Drug: Placebo foam
One application of placebo foam once daily for 8 weeks
Other Name: placebo
|
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
Locations
| Germany | |
| Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig | |
| Braunschweig, Germany, 38114 | |
| Strahlentherapie, St. Vincentius-Kliniken gAG | |
| Karlsruhe, Germany, 76135 | |
| Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen | |
| Trier, Germany, 54290 | |
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 |
| ClinicalTrials.gov Identifier: | NCT00828230 History of Changes |
| Other Study ID Numbers: | BUF-17/RAP, EudraCT No.: 2007-002082-13 |
| Study First Received: | January 22, 2009 |
| Last Updated: | January 26, 2012 |
| 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:
|
Proctitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Rectal Diseases Intestinal Diseases Budesonide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013