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Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Primary Purpose

Radiation Proctitis

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
budesonide
Placebo foam
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiation Proctitis focused on measuring budesonide, placebo, acute radiation proctitis, late radiation proctitis, Prevention of acute radiation proctitis, Prevention of late radiation proctitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig
  • Strahlentherapie, St. Vincentius-Kliniken gAG
  • Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

2mg rectal budesonide per day for 8 weeks

One application of placebo foam once daily for 8 weeks

Outcomes

Primary Outcome Measures

Proportion of patients developing radiation proctitis during treatment or need rescue medication

Secondary Outcome Measures

Time to occurrence of acute radiation proctitis
Time to occurrence of chronic radiation proctitis
Adverse Events (AEs)

Full Information

First Posted
January 22, 2009
Last Updated
January 26, 2012
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00828230
Brief Title
Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Proctitis
Keywords
budesonide, placebo, acute radiation proctitis, late radiation proctitis, Prevention of acute radiation proctitis, Prevention of late radiation proctitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
2mg rectal budesonide per day for 8 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
One application of placebo foam once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
budesonide
Other Intervention Name(s)
Budenofalk rectal foam
Intervention Description
One application of 2mg budesonide once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo foam
Other Intervention Name(s)
placebo
Intervention Description
One application of placebo foam once daily for 8 weeks
Primary Outcome Measure Information:
Title
Proportion of patients developing radiation proctitis during treatment or need rescue medication
Time Frame
within 8 weeks
Secondary Outcome Measure Information:
Title
Time to occurrence of acute radiation proctitis
Time Frame
During 8 weeks
Title
Time to occurrence of chronic radiation proctitis
Time Frame
Within 1 year
Title
Adverse Events (AEs)
Time Frame
During 8 weeks of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Mueller, Dr
Organizational Affiliation
Dr. Falk Pharma GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Strahlentherapie, St. Vincentius-Kliniken gAG
City
Karlsruhe
ZIP/Postal Code
76135
Country
Germany
Facility Name
Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen
City
Trier
ZIP/Postal Code
54290
Country
Germany

12. IPD Sharing Statement

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Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

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