NCT00828230

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

January 22, 2009

Last Update Submit

January 26, 2012

Conditions

Radiation Proctitis

Keywords

budesonideplaceboacute radiation proctitislate radiation proctitisPrevention of acute radiation proctitisPrevention of late radiation proctitis

Outcome Measures

Primary Outcomes (1)

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

    within 8 weeks

Secondary Outcomes (3)

  • Time to occurrence of acute radiation proctitis

    During 8 weeks

  • Time to occurrence of chronic radiation proctitis

    Within 1 year

  • Adverse Events (AEs)

    During 8 weeks of treatment

Study Arms (2)

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

budesonideDRUG

One application of 2mg budesonide once daily for 8 weeks

Also known as: Budenofalk rectal foam
1
Placebo foamDRUG

One application of placebo foam once daily for 8 weeks

Also known as: placebo
2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig

Braunschweig, 38114, Germany

Location

Strahlentherapie, St. Vincentius-Kliniken gAG

Karlsruhe, 76135, Germany

Location

Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen

Trier, 54290, Germany

Location

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ralph Mueller, Dr

    Dr. Falk Pharma GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations

DE(3)