Microscopic ColitisPhase 3NCT00180050
Budesonide Treatment for Lymphocytic Colitis
A Phase 3 study testing Budesonide in people with Microscopic 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 the treatment of lymphocytic colitis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Microscopic Colitis
- What is being tested?
- Budesonide
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to Aug 2007
- 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
- lymphocytic colitis
- diarrhea
- effective contraception
- written informed consent
Who cannot join
- other forms if IBD
- celiac disease
- infectious colitis
- history of colonic surgery
- use of budesonide, 5-ASA, steroids within th previous 4 weeks
- pregnancy, lactation
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 for Treatment of Lymphocytic Colitis
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
Read the detailed description
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
- Conditions
- Microscopic Colitis
- Being tested
- Budesonide
- Keywords
- lymphocytic colitis, microscopic colitis, budesonide
- Medical subject headings
- Colitis, Microscopic, Colitis, Lymphocytic
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 weeks
Secondary outcomes (3)
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 startJan 2002
- Primary completionAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microscopic 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Investigators
- Stephan Miehlke, Prof., Principal investigator, Medical Department I, Technical University Hospital, Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180050
- Sponsor's protocol ID
- BLYCK
- 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 for Treatment of Lymphocytic Colitis
- ClinicalTrials.gov ID
- NCT00180050
- Acronym / sponsor ID
- BLYCK
- Conditions
- Microscopic Colitis
- Keywords
- lymphocytic colitis, microscopic colitis, budesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Study start
- Jan 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2007 (actual)
- 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 the treatment of lymphocytic colitis
Detailed description
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic 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 (4 listed)
- lymphocytic colitis
- diarrhea
- effective contraception
- written informed consent
Key exclusion criteria (6 listed)
- other forms if IBD
- celiac disease
- infectious colitis
- history of colonic surgery
- use of budesonide, 5-ASA, steroids within th previous 4 weeks
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 weeks
3 secondary outcomes
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.
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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.
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 Microscopic 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 4 inclusion and 6 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 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 Mar 2010.