Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: AstraZeneca; National Center for Research Resources (NCRR)
• Treatments: Budesonide

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.