Budesonide Foam Versus Placebo for Prevention of Acute Ra... | NCT00828230

Studies
Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

NCT00828230

Sponsor

Dr. Falk Pharma GmbH

Status

Terminated

Last Update Posted

Jan 30, 2012Estimated

Enrollment

17Actual

Phase

Phase 2

Conditions

Radiation Proctitis

Interventions

budesonide
Placebo foam

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT No.: 2007-002082-13

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Aug 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jan 22, 2009

First Submission Date that Met QC Criteria

Jan 22, 2009

First Posted Date

Jan 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2012

Last Update Posted Date

Jan 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	2mg rectal budesonide per day for 8 weeks	Drug: budesonide
2	Placebo Comparator	One application of placebo foam once daily for 8 weeks	Drug: Placebo foam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
budesonide	Drug	One application of 2mg budesonide once daily for 8 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients developing radiation proctitis during treatment or need rescue medication		within 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to occurrence of acute radiation proctitis		During 8 weeks
Time to occurrence of chronic radiation proctitis		Within 1 year
Adverse Events (AEs)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473