Status:
TERMINATED
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
AstraZeneca
National Center for Research Resources (NCRR)
Conditions:
Lymphocytic Colitis
Diarrhea
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
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 hy...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00217022
Start Date
June 1 2003
End Date
February 1 2008
Last Update
November 2 2021
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905