Collagenous ColitisPhase 3NCT00450086
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
A Phase 3 study testing Budesonide and Mesalazine in people with Collagenous Colitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Collagenous Colitis
- What is being tested?
- Budesonide and Mesalazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Aug 2011
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 4 watery/soft stools on at least 4 days in the week prior to baseline
- > 3 stools per day on average within the last 7 days prior to baseline
- Symptoms (chronic watery diarrhea) for at least 3 months before baseline
- Complete colonoscopy within the last 12 weeks before baseline
- Histologically confirmed diagnosis of collagenous colitis
Who cannot join
- Evidence of infectious diarrhea
- Celiac disease
- Endoscopic-histologic findings, which may have caused diarrhea
- History of partial colonic resection
- Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
- Active colorectal cancer or a history of colorectal cancer
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- Severe co-morbidity substantially reducing life expectancy
- Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN)
- Abnormal renal function (Cystatin C > ULN)
- Active peptic ulcer disease, local intestinal infection
- Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
- Hemorrhagic diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules vs. Mesalazine Granules vs. Placebo for Patients With Collagenous Colitis.
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.
Read the detailed description
This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.
- Conditions
- Collagenous Colitis
- Being tested
- Budesonide, Mesalazine, Placebo
- Medical subject headings
- Colitis, Collagenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
9 mg per day
MesalazineDrug
3 g per day
PlaceboDrug
0 g per day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Budesonide |
| B | Experimental | Not described Receives: Drug: Mesalazine |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical remission (<= 3 stools per day) after 8 weeks
Measured: 8 weeks
Secondary outcomes (9)
Rate of clinical remission (<= 3 stools per day) after 2 weeks
Measured: 2 weeks
Time to remission
Impact on stool consistency (watery/soft/solid)
Measured: 8 weeks
Impact on abdominal pain
Measured: 8 weeks
Impact on patient's general well-being
Measured: 8 weeks
Effect on histopathology
Measured: 8 weeks
Severity of diarrhea
Measured: 8 weeks
QoL
Measured: 8 weeks
PGA
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Collagenous ColitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Miehlke, Professor, Principal investigator, Center for digestive diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450086
- Sponsor's protocol ID
- BUC-60/COC
- Other IDs
- 2006-004159-39
- Status last verified
- May 2014
- First submitted
- 20 Mar 2007
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miehlke S, Madisch A, Kupcinskas L, Petrauskas D, Bohm G, Marks HJ, Neumeyer M, Nathan T, Fernandez-Banares F, Greinwald R, Mohrbacher R, Vieth M, Bonderup OK; BUC-60/COC Study Group. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. Gastroenterology. 2014 May;146(5):1222-30.e1-2. doi: 10.1053/j.gastro.2014.01.019. Epub 2014 Jan 15.
PubMed 24440672
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules vs. Mesalazine Granules vs. Placebo for Patients With Collagenous Colitis.
- ClinicalTrials.gov ID
- NCT00450086
- Acronym / sponsor ID
- BUC-60/COC
- Conditions
- Collagenous Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Mar 2007 (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.
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.
Detailed description
This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Budesonide |
| B | Experimental | Drug: Mesalazine |
| C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 4 watery/soft stools on at least 4 days in the week prior to baseline
- > 3 stools per day on average within the last 7 days prior to baseline
- Symptoms (chronic watery diarrhea) for at least 3 months before baseline
- Complete colonoscopy within the last 12 weeks before baseline
- Histologically confirmed diagnosis of collagenous colitis
Key exclusion criteria (12 listed)
- Evidence of infectious diarrhea
- Celiac disease
- Endoscopic-histologic findings, which may have caused diarrhea
- History of partial colonic resection
- Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
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 |
|---|---|---|
| Budesonide9 mg per day | Drug | A |
| Mesalazine3 g per day | Drug | B |
| Placebo0 g per day | Drug | C |
Primary outcome
Rate of clinical remission (<= 3 stools per day) after 8 weeks
Time frame: 8 weeks
9 secondary outcomes
Rate of clinical remission (<= 3 stools per day) after 2 weeks
Time frame: 2 weeks
Time to remission
Impact on stool consistency (watery/soft/solid)
Time frame: 8 weeks
Impact on abdominal pain
Time frame: 8 weeks
Impact on patient's general well-being
Time frame: 8 weeks
Effect on histopathology
Time frame: 8 weeks
Severity of diarrhea
Time frame: 8 weeks
QoL
Time frame: 8 weeks
PGA
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Results publication: PubMed 24440672Miehlke S, Madisch A, Kupcinskas L, Petrauskas D, Bohm G, Marks HJ, Neumeyer M, Nathan T, Fernandez-Banares F, Greinwald R, Mohrbacher R, Vieth M, Bonderup OK; BUC-60/COC Study Group. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. Gastroenterology. 2014 May;146(5):1222-30.e1-2. doi: 10.1053/j.gastro.2014.01.019. Epub 2014 Jan 15.
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.
Stephan Miehlke, Professor principal investigator
Center for digestive diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide and Mesalazine in people with Collagenous Colitis, run by Dr. Falk Pharma GmbH at 1 site 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of clinical remission (<= 3 stools per day) after 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00450086, which also lists 1 linked publication.
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 19 May 2014.