Radiation ProctitisPhase 2NCT00828230
Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
A Phase 2 study testing budesonide in people with Radiation Proctitis, run by Dr. Falk Pharma GmbH at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Radiation Proctitis
- What is being tested?
- budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2008to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig
Braunschweig, 38114
Strahlentherapie, St. Vincentius-Kliniken gAG
Karlsruhe, 76135
Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen
Trier, 54290
About this 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
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.
- Conditions
- Radiation Proctitis
- Being tested
- budesonide, Placebo foam
- Keywords
- budesonide, placebo, acute radiation proctitis, late radiation proctitis, Prevention of acute radiation proctitis, Prevention of late radiation proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
Also called Budenofalk rectal foam
One application of 2mg budesonide once daily for 8 weeks
Placebo foamDrug
Also called placebo
One application of placebo foam once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2mg rectal budesonide per day for 8 weeks Receives: Drug: budesonide |
| 2 | Placebo comparator | One application of placebo foam once daily for 8 weeks Receives: Drug: Placebo foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients developing radiation proctitis during treatment or need rescue medication
Measured: within 8 weeks
Secondary outcomes (3)
Time to occurrence of acute radiation proctitis
Measured: During 8 weeks
Time to occurrence of chronic radiation proctitis
Measured: Within 1 year
Adverse Events (AEs)
Measured: During 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionOct 2011
Why it stopped: Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProctitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Mueller, Dr, Study director, Dr. Falk Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828230
- Sponsor's protocol ID
- BUF-17/RAP
- Other IDs
- EudraCT No.: 2007-002082-13
- Status last verified
- Jan 2012
- First submitted
- 22 Jan 2009
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00828230
- Acronym / sponsor ID
- BUF-17/RAP
- Conditions
- Radiation Proctitis
- Keywords
- budesonide, placebo, acute radiation proctitis, late radiation proctitis, Prevention of acute radiation proctitis, Prevention of late radiation proctitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide2mg rectal budesonide per day for 8 weeks |
| 2 | Placebo comparator | Drug: Placebo foamOne application of placebo foam once daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonideAlso: Budenofalk rectal foamOne application of 2mg budesonide once daily for 8 weeks | Drug | 1 |
| Placebo foamAlso: placeboOne application of placebo foam once daily for 8 weeks | Drug | 2 |
Primary outcome
Proportion of patients developing radiation proctitis during treatment or need rescue medication
Time frame: within 8 weeks
3 secondary outcomes
Time to occurrence of acute radiation proctitis
Time frame: During 8 weeks
Time to occurrence of chronic radiation proctitis
Time frame: Within 1 year
Adverse Events (AEs)
Time frame: During 8 weeks of treatment
Results and safety
The study was stopped early (reason given: Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Mueller, Dr study director
Dr. Falk Pharma GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing budesonide in people with Radiation Proctitis, run by Dr. Falk Pharma GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was prematurely stopped due to slow recruitment after 17 of 32 anticipated patients were recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients developing radiation proctitis during treatment or need rescue medication (time frame: within 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2012.