Lymphocytic ColitisPhase 3NCT01209208
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis
A Phase 3 study testing Budesonide and Mesalamine in people with Lymphocytic 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 lymphocytic colitis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymphocytic Colitis
- What is being tested?
- Budesonide and Mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Jun 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Symptoms and signs of indication of lymphocytic colitis
Who cannot join
- Infectious diarrhoea,
- Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
- Pregnancy or breast-feeding,
- Participation in an other clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf
Hamburg
About this study
Official title: Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Study on the Efficacy and Tolerability of a 8-week Treatment With Budesonide vs. Mesalazine vs. Placebo in Patients With Lymphocytic Colitis
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.
- Conditions
- Lymphocytic Colitis
- Being tested
- Budesonide, Mesalamine, Placebo
- Medical subject headings
- Colitis, Lymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
9 mg per day
MesalamineDrug
3 g per day
PlaceboOther
0 g per day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Budesonide Receives: Drug: Budesonide |
| B | Experimental | Mesalazine Receives: Drug: Mesalamine |
| C | Placebo comparator | Not described Receives: Other: Placebo |
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 (1)
Proportion of patients with histological improvement
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 posted27 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2017
- Study completionJun 2017
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 Lymphocytic 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
- 57 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, Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209208
- Sponsor's protocol ID
- BUG-1/LMC
- Other IDs
- 2008-005994-36, 2008
- Status last verified
- Jul 2017
- First submitted
- 23 Sep 2010
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miehlke S, Aust D, Mihaly E, Armerding P, Bohm G, Bonderup O, Fernandez-Banares F, Kupcinskas J, Munck LK, Rehbehn KU, Nacak T, Greinwald R, Munch A; BUG-1/LMC Study Group. Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis. Gastroenterology. 2018 Dec;155(6):1795-1804.e3. doi: 10.1053/j.gastro.2018.08.042. Epub 2018 Sep 7.
PubMed 30195447
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. 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 Study on the Efficacy and Tolerability of a 8-week Treatment With Budesonide vs. Mesalazine vs. Placebo in Patients With Lymphocytic Colitis
- ClinicalTrials.gov ID
- NCT01209208
- Acronym / sponsor ID
- BUG-1/LMC
- Conditions
- Lymphocytic Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Sep 2010 (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 lymphocytic colitis.
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: BudesonideBudesonide |
| B | Experimental | Drug: MesalamineMesalazine |
| C | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Symptoms and signs of indication of lymphocytic colitis
Key exclusion criteria (4 listed)
- Infectious diarrhoea,
- Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
- Pregnancy or breast-feeding,
- Participation in an other clinical trial
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 |
| Mesalamine3 g per day | Drug | B |
| Placebo0 g per day | Other | C |
Primary outcome
Rate of clinical remission
Time frame: 8 weeks
1 secondary outcome
Proportion of patients with histological improvement
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 26 Jul 2017.
- Derived from this study: PubMed 30195447Miehlke S, Aust D, Mihaly E, Armerding P, Bohm G, Bonderup O, Fernandez-Banares F, Kupcinskas J, Munck LK, Rehbehn KU, Nacak T, Greinwald R, Munch A; BUG-1/LMC Study Group. Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis. Gastroenterology. 2018 Dec;155(6):1795-1804.e3. doi: 10.1053/j.gastro.2018.08.042. Epub 2018 Sep 7.
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
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, 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 and Mesalamine in people with Lymphocytic 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 2 inclusion and 4 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 26 Jul 2017. 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 (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 NCT01209208, 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 26 Jul 2017.