Incomplete Microscopic ColitisPhase 3NCT02142634
Budesonide for Induction of Remission in Incomplete Microscopic Colitis
A Phase 3 study testing Budesonide granules 9 mg in people with Incomplete Microscopic Colitis, run by Dr. Falk Pharma GmbH at 2 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incomplete Microscopic Colitis
- What is being tested?
- Budesonide granules 9 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2014to Feb 2020
- 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
- Histologically established diagnosis of incomplete microscopic colitis (MCi)
- History of chronic non-bloody, watery diarrhoea
- Clinically active disease
Who cannot join
- Other significant abnormalities in colonoscopy
- Infectious cause of diarrhoea
- Clinical suspicion of drug-induced diarrhoea
- Prior and present MC
- History of bowel resection
- Radiation therapy of the abdominal or pelvic region
Show all 17Show fewer
- Positive antibody titres for celiac disease
- Untreated active thyroid dysfunction
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
- Abnormal hepatic function
- Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
- History of colorectal cancer
- History of cancer (other than colorectal) in the last 5 years
- Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
- Current or intended pregnancy or breast-feeding
- Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
- 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
2 sites in 2 countries.
2 sites in 2 countries
Sweden1 site
University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
Linköping, 58185
About this study
Official title: Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
- Conditions
- Incomplete Microscopic Colitis
- Being tested
- Budesonide granules 9 mg, Placebo granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide granules 9 mgDrug
per day
Placebo granulesDrug
per day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Budesonide granules 9 mg Receives: Drug: Budesonide granules 9 mg |
| B | Placebo comparator | Placebo granules Receives: Drug: Placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical remission
Measured: 8 weeks
Secondary outcomes (9)
Rate of clinical remission
Measured: 2 weeks
Rate of clinical remission
Measured: 6 weeks
Time to remission
Measured: 8 weeks
Number of formed/soft/watery stools per week
Measured: 8 weeks
Number of days with abdominal pain
Measured: 8 weeks
Number of days with urgency
Measured: 8 weeks
Rate of histological remission
Measured: 8 weeks
Physician's global assessment at final visit
Measured: 8 weeks
Quality of life
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 posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Microscopic 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Münch, MD, Principal investigator, University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142634
- Sponsor's protocol ID
- BUG-3/MIC
- Other IDs
- 2013-001912-31
- Status last verified
- Jul 2020
- First submitted
- 14 May 2014
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis
- ClinicalTrials.gov ID
- NCT02142634
- Acronym / sponsor ID
- BUG-3/MIC
- Conditions
- Incomplete Microscopic Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 20 May 2014 (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 demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Budesonide granules 9 mgBudesonide granules 9 mg |
| B | Placebo comparator | Drug: Placebo granulesPlacebo granules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically established diagnosis of incomplete microscopic colitis (MCi)
- History of chronic non-bloody, watery diarrhoea
- Clinically active disease
Key exclusion criteria (17 listed)
- Other significant abnormalities in colonoscopy
- Infectious cause of diarrhoea
- Clinical suspicion of drug-induced diarrhoea
- Prior and present MC
- History of bowel resection
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 granules 9 mgper day | Drug | A |
| Placebo granulesper day | Drug | B |
Primary outcome
Rate of clinical remission
Time frame: 8 weeks
9 secondary outcomes
Rate of clinical remission
Time frame: 2 weeks
Rate of clinical remission
Time frame: 6 weeks
Time to remission
Time frame: 8 weeks
Number of formed/soft/watery stools per week
Time frame: 8 weeks
Number of days with abdominal pain
Time frame: 8 weeks
Number of days with urgency
Time frame: 8 weeks
Rate of histological remission
Time frame: 8 weeks
Physician's global assessment at final visit
Time frame: 8 weeks
Quality of life
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 22 Jul 2020.
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.
Andreas Münch, MD principal investigator
University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide granules 9 mg in people with Incomplete Microscopic Colitis, run by Dr. Falk Pharma GmbH at 2 sites in 2 countries.
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 17 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Sweden. 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 (time frame: 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 22 Jul 2020.