Induction and Maintaining Remission of Collagenous ColitisPhase 3SCCMSNCT01278082
SOIBD Collagenous Colitis Maintenance Study
A Phase 3 study testing Budesonide in people with Induction and Maintaining Remission of Collagenous Colitis, run by Dr. Falk Pharma GmbH at 2 sites in 2 countries.
Trial summary
This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Induction and Maintaining Remission of Collagenous Colitis
- What is being tested?
- Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2008to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent,
- Patients aged >= 18 years,
- Histologically established diagnosis of collagenous colitis (CC) defined as:
- Thickened sub-epithelial collagen layer >= 10 µm on well-orientated sections,
- Increased amount of inflammatory cells indicating chronic inflammation in the lamina propria,
- History of non-bloody, watery diarrhoea for more than 2 weeks prior screening in patients with newly diagnosed collagenous colitis, or history of clinical relapse for more than 1 week prior screening in patients with previously established collagenous colitis,
- A mean of >= 3 stools/day, thereof a mean of >= 1 watery stools/day, during the week prior baseline,
- Women of child-bearing potential and being heterosexually active have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
Who cannot join
- Other significant abnormalities at colonoscopy that may have been the cause of diarrhoea, with the exception of colonic diverticulosis and polyps < 2 cm,
- Infectious cause of diarrhoea,
- Untreated active celiac disease,
- Clinical suspicion of drug-induced collagenous colitis,
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
- Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
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- Local intestinal infection,
- Radiation therapy towards the abdominal or pelvic region,
- Diabetes mellitus, infection, glaucoma, tuberculosis, peptic ulcer disease, or hypertension if careful medical monitoring is not ensured,
- Known established cataract,
- Known hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency, Lapp lactase deficiency, or congenital lactase deficiency,
- Established osteoporosis with T-score < -2.5,
- Pregnancy or lactation,
- History of cancer in the last five years,
- History of significant bowel resection,
- Therapy with immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) in the last 3 months,
- Treatment with oral, rectal, or intravenous corticosteroids including budesonide in the last month,
- Known intolerance/hypersensitivity to study drug or drugs of similar chemical structure or pharmacological profile,
- Patients who are unable to adhere to the study visit schedule and other protocol requirements according to the judgement of the investigator,
- 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
About this study
Official title: Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules Versus Placebo for Maintenance of Remission in Patients With Collagenous Colitis
This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period
- Being tested
- Budesonide, Placebo
- Keywords
- Randomized, double-blind, Placebo-controlled, budesonide, collagenous colitis, acute treatment, maintaining remission
- 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
Also called Budenofalk 3mg capsules
Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day
PlaceboDrug
Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day Receives: Drug: Budesonide |
| B | Placebo comparator | Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients being in remission over 52 weeks.
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
Measured: 52 weeks
Secondary outcomes (2)
Proportion of patients in remission at wk 4, 13, 26, and 39.
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
Measured: 39 weeks
Adverse events (AEs)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startApr 2008
- Primary completionMar 2013
- Study completionSep 2013
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 Induction and Maintaining Remission of 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)
- Collaborators
- The Swedish Organization for Studies on Inflammatory Bowel Disease
- Responsible party
- Sponsor
- Investigators
- Ralph Müller, Dr, Study director, Dr. Falk Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278082
- Sponsor's protocol ID
- BUC-63/COC
- Other IDs
- 2007-001315-31
- Acronym
- SCCMS
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2011
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Munch A, Bohr J, Miehlke S, Benoni C, Olesen M, Ost A, Strandberg L, Hellstrom PM, Hertervig E, Armerding P, Stehlik J, Lindberg G, Bjork J, Lapidus A, Lofberg R, Bonderup O, Avnstrom S, Rossle M, Dilger K, Mueller R, Greinwald R, Tysk C, Strom M; BUC-63 investigators. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial. Gut. 2016 Jan;65(1):47-56. doi: 10.1136/gutjnl-2014-308363. Epub 2014 Nov 25.
PubMed 25425655
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules Versus Placebo for Maintenance of Remission in Patients With Collagenous Colitis
- ClinicalTrials.gov ID
- NCT01278082
- Acronym / sponsor ID
- SCCMS / BUC-63/COC
- Keywords
- Randomized, double-blind, Placebo-controlled, budesonide, collagenous colitis, acute treatment, maintaining remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- The Swedish Organization for Studies on Inflammatory Bowel Disease
- Study start
- Apr 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Jan 2011 (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.
This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period
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: BudesonideAlternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day |
| B | Placebo comparator | Drug: PlaceboAlternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent,
- Patients aged >= 18 years,
- Histologically established diagnosis of collagenous colitis (CC) defined as:
- History of non-bloody, watery diarrhoea for more than 2 weeks prior screening in patients with newly diagnosed collagenous colitis, or history of clinical relapse for more than 1 week prior screening in patients with previously established collagenous colitis,
- A mean of >= 3 stools/day, thereof a mean of >= 1 watery stools/day, during the week prior baseline,
Key exclusion criteria (20 listed)
- Other significant abnormalities at colonoscopy that may have been the cause of diarrhoea, with the exception of colonic diverticulosis and polyps < 2 cm,
- Infectious cause of diarrhoea,
- Untreated active celiac disease,
- Clinical suspicion of drug-induced collagenous colitis,
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
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 3mg capsulesAlternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day | Drug | A |
| PlaceboAlternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day. | Drug | B |
Primary outcome
Proportion of patients being in remission over 52 weeks.
Time frame: 52 weeks
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
2 secondary outcomes
Proportion of patients in remission at wk 4, 13, 26, and 39.
Time frame: 39 weeks
Adverse events (AEs)
Time frame: 52 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 21 Jan 2016.
- Results publication: PubMed 25425655Munch A, Bohr J, Miehlke S, Benoni C, Olesen M, Ost A, Strandberg L, Hellstrom PM, Hertervig E, Armerding P, Stehlik J, Lindberg G, Bjork J, Lapidus A, Lofberg R, Bonderup O, Avnstrom S, Rossle M, Dilger K, Mueller R, Greinwald R, Tysk C, Strom M; BUC-63 investigators. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial. Gut. 2016 Jan;65(1):47-56. doi: 10.1136/gutjnl-2014-308363. Epub 2014 Nov 25.
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 Müller, Dr study director
Dr. Falk Pharma GmbH
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 in people with Induction and Maintaining Remission of Collagenous 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 8 inclusion and 20 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 21 Jan 2016. 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?
Proportion of patients being in remission over 52 weeks. (time frame: 52 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 NCT01278082, 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 21 Jan 2016.