Lymphocytic ColitisPhase 2/3NCT00217022
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
A Phase 2/3 study testing Budesonide in people with Lymphocytic Colitis and Diarrhea, run by Mayo Clinic at 1 site in United States.
Trial summary
Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lymphocytic Colitis, Diarrhea
- 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Feb 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment.
- Lymphocytic colitis confirmed histologically within one year of enrollment
Who cannot join
- Previous unsuccessful treatment with corticosteroids or immunosuppressive drugs
- History of severe corticosteroid side effects
- Corticosteroid, ticlopidine, or flutamide use within the previous 4 weeks
- Antibiotic, mesalamine or bismuth subsalicylate use within two weeks
- Current use of anticholinergics, cholestyramine, narcotics, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or grapefruit juice
- Known active medical conditions, including cancer, infection, uncontrolled hypertension or diabetes, osteoporosis, peptic ulcer disease, glaucoma, cataracts, liver cirrhosis or history of tuberculosis
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- Other diarrheal conditions (sprue, infection, hyperthyroidism, lactose intolerance)
- Pregnant or nursing females
- Patients without a telephone or unable to communicate in English over the telephone, or unable or unwilling to give consent
- Known hypersensitivity to or intolerance of budesonide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis
Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.
Read the detailed description
Microscopic colitis is an increasingly diagnosed cause of chronic diarrhea, with two main subtypes: collagenous and lymphocytic colitis. Uncontrolled reports have suggested that various drugs can be beneficial in treating microscopic colitis, but few treatments have been evaluated in randomized controlled trials. Thus, treatment is guided mostly by anecdotal reports, case series, and physicians' experience. In our uncontrolled experience, corticosteroids are one of the most effective therapies for microscopic colitis, but are not typically used as a first line therapy because of toxicity. Budesonide has been reported to be of clinical benefit in small, uncontrolled series of patients with microscopic colitis, and recent controlled trials showed that it is superior to placebo in collagenous colitis. We propose a study of budesonide in patients with the lymphocytic type of microscopic colitis.
Patients will have stool specimen and blood drawn at the start of the study. Patient will take either Budesonide or placebo for 8 weeks. At the end of treatment, patient will have stool collection and sigmoidoscopy.
- Conditions
- Lymphocytic Colitis, Diarrhea
- Being tested
- Placebo, Budesonide
- Keywords
- Lymphocytic Colitis, diarrhea, budesonide
- Medical subject headings
- Colitis, Lymphocytic, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo, 3 tablets daily
BudesonideDrug
Also called Entocort EC
9 mg daily (three tablets)
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Active comparator | 9 mg daily Receives: Drug: Budesonide |
| Placebo | Placebo comparator | three tablets daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks
Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks.
Measured: Three out of last four weeks that the subject was on the study
Secondary outcomes (1)
Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies
The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale ("normal" (0), "mildly increased" (1), "moderately increased" (2), "severely increased" (3)).
Measured: Baseline (day 1 of study) and at eight weeks (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: Study closed early, because of low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphocytic ColitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Darrell S. Pardi, M.D., Mayo Clinic
- Investigators
- Darrell S. Pardi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217022
- Sponsor's protocol ID
- 1132-03
- Other IDs
- IRUSBUEN0002, UL1RR024150
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2005
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis
- ClinicalTrials.gov ID
- NCT00217022
- Acronym / sponsor ID
- 1132-03
- Conditions
- Lymphocytic Colitis, Diarrhea
- Keywords
- Lymphocytic Colitis, diarrhea, budesonide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed early, because of low enrollment.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- AstraZeneca, National Center for Research Resources (NCRR)
- Study start
- Jun 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 12 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.
Detailed description
Microscopic colitis is an increasingly diagnosed cause of chronic diarrhea, with two main subtypes: collagenous and lymphocytic colitis. Uncontrolled reports have suggested that various drugs can be beneficial in treating microscopic colitis, but few treatments have been evaluated in randomized controlled trials. Thus, treatment is guided mostly by anecdotal reports, case series, and physicians' experience. In our uncontrolled experience, corticosteroids are one of the most effective therapies for microscopic colitis, but are not typically used as a first line therapy because of toxicity. Budesonide has been reported to be of clinical benefit in small, uncontrolled series of patients with microscopic colitis, and recent controlled trials showed that it is superior to placebo in collagenous colitis. We propose a study of budesonide in patients with the lymphocytic type of microscopic colitis.
Patients will have stool specimen and blood drawn at the start of the study. Patient will take either Budesonide or placebo for 8 weeks. At the end of treatment, patient will have stool collection and sigmoidoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Active comparator | Drug: Budesonide9 mg daily |
| Placebo | Placebo comparator | Other: Placebothree tablets daily |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment.
- Lymphocytic colitis confirmed histologically within one year of enrollment
Key exclusion criteria (10 listed)
- Previous unsuccessful treatment with corticosteroids or immunosuppressive drugs
- History of severe corticosteroid side effects
- Corticosteroid, ticlopidine, or flutamide use within the previous 4 weeks
- Antibiotic, mesalamine or bismuth subsalicylate use within two weeks
- Current use of anticholinergics, cholestyramine, narcotics, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or grapefruit juice
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 |
|---|---|---|
| PlaceboPlacebo, 3 tablets daily | Other | Placebo |
| BudesonideAlso: Entocort EC9 mg daily (three tablets) | Drug | Budesonide |
Primary outcome
Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks
Time frame: Three out of last four weeks that the subject was on the study
Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks.
1 secondary outcome
Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies
Time frame: Baseline (day 1 of study) and at eight weeks (approximately)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Darrell S. Pardi, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Budesonide in people with Lymphocytic Colitis and Diarrhea, run by Mayo Clinic at 1 site in United States.
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 10 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: stopped early, as of the sponsor's last update on 2 Nov 2021. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 12 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks (time frame: Three out of last four weeks that the subject was on the study). 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 2 Nov 2021.