Collagenous ColitisPhase 3NCT00180076
Budesonide for Maintenance Treatment of Collagenous Colitis
A Phase 3 study testing Budesonide in people with Collagenous Colitis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with 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
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to Mar 2008
- 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
- collagenous colitis
- diarrhea
- written informed consent
Who cannot join
- infectious causes for diarrhea
- other inflammatory bowel diseases
- history of colonic surgery
- celiac disease
- malignancies
- severe concomitant diseases
Show all 12Show fewer
- use of budesonide, steroids, mesalazine within the previous 2 weeks
- known intolerance to budesonide
- history of lack of response to budesonide
- pregnancy,lactation
- drug and/or alcohol abuse
- lack of compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Department I, Technical University Hospital
Dresden, 01307
About this study
Official title: Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
Read the detailed description
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
- Conditions
- Collagenous Colitis
- Being tested
- Budesonide
- Keywords
- collagenous colitis, microscopic colitis, budesonide
- Medical subject headings
- Colitis, Collagenous, Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in clinical remission after 6 months
Secondary outcomes (4)
time to relapse
safety
quality of life
histological improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagenous ColitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Stephan Miehlke, Prof., Principal investigator, Medical Department I, Technical University Hospital, Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180076
- Sponsor's protocol ID
- MIMIC
- Status last verified
- Mar 2010
- First submitted
- 9 Sep 2005
- Last updated
- 30 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis
- ClinicalTrials.gov ID
- NCT00180076
- Acronym / sponsor ID
- MIMIC
- Conditions
- Collagenous Colitis
- Keywords
- collagenous colitis, microscopic colitis, budesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2008
- First posted
- 16 Sep 2005 (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 orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
Detailed description
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- collagenous colitis
- diarrhea
- written informed consent
Key exclusion criteria (12 listed)
- infectious causes for diarrhea
- other inflammatory bowel diseases
- history of colonic surgery
- celiac disease
- malignancies
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 |
|---|---|---|
| Budesonide | Drug | – |
Primary outcome
Proportion of patients in clinical remission after 6 months
4 secondary outcomes
time to relapse
safety
quality of life
histological improvement
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 30 Mar 2010.
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, Prof. principal investigator
Medical Department I, Technical University Hospital, Dresden, Germany
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 in people with Collagenous Colitis, run by Technische Universität Dresden 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 3 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 30 Mar 2010. 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. 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?
Proportion of patients in clinical remission after 6 months. 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 Mar 2010.