Back to resultsBudesonide Versus Placebo for the Treatment of Lymphocytic Colitis
Primary Purpose
Lymphocytic Colitis, Diarrhea
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Budesonide
Sponsored by
About this trial
This is an interventional treatment trial for Lymphocytic Colitis focused on measuring Lymphocytic Colitis, diarrhea, budesonide
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Budesonide
Placebo
Arm Description
9 mg daily
three tablets daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)).
Full Information
NCT ID
NCT00217022
First Posted
September 14, 2005
Last Updated
October 28, 2021
Sponsor
Mayo Clinic
Collaborators
AstraZeneca, National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00217022
Brief Title
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
Official Title
A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Study closed early, because of low enrollment.
Study Start Date
June 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
AstraZeneca, National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Colitis, Diarrhea
Keywords
Lymphocytic Colitis, diarrhea, budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Budesonide
Arm Type
Active Comparator
Arm Description
9 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
three tablets daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, 3 tablets daily
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Entocort EC
Intervention Description
9 mg daily (three tablets)
Primary Outcome Measure Information:
Title
Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks
Description
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.
Time Frame
Three out of last four weeks that the subject was on the study
Secondary Outcome Measure Information:
Title
Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies
Description
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)).
Time Frame
Baseline (day 1 of study) and at eight weeks (approximately)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrell S. Pardi, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
We'll reach out to this number within 24 hrs