The purpose of this research study is to compare how well two formulations of budesonide (budesonide MMX \[Cortiment\] and budesonide CR \[Entocort\]) work for treating patients with microscopic colitis.
Male or non-pregnant, non-lactating females, 18-80 years old years of age
Females of childbearing potential must be taking adequate contraceptive precautions (i.e., implants, injectables, hormonal intrauterine devices, combined hormonal contraceptives, having a vasectomized partner or total abstinence from heterosexual relations with no plans of becoming pregnant through insemination or in vitro fertilization) and have a negative urine pregnancy test prior to randomization.
Active symptoms of MC defined by non-bloody, watery diarrhea or loose bowel movements for at least 12 weeks (for patients with newly diagnosed MC) or a history of clinical relapse for at least one week before randomization in patients with previously established MC, and with >=28 stools within 7 days preceding randomization, of which >=20 were watery/soft stools
lymphocytic colitis: ≥20 IELs/100 surface epithelial cells
Evidence of infectious diarrhea (proved by stool culture or colonic biopsy), diarrhea due to other organic diseases of the gastrointestinal tract including Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease (ruled out by either duodenal biopsy or serum antibodies), radiation colitis, or polyps >2cm, suspicion of drug-induced MC
History of partial or total colonic resection
Previous exposure to >7 days of any budesonide formulation for treatment of MC
Unwillingness to withhold protocol-proscribed medications during the trial
Parallel
Budesonide MMX®
Drug9 mg delayed and extended-release tablet once daily
Budesonide controlled ileal release (CR) capsules
Drugthree 3 mg capsules daily oral administration for 8 weeks
Clinical remission
Hjortswang criteria defines clinical remission as a daily average \<3 loose/watery bowel movements per 24 hours in the week preceding the final assessment (loose/watery stool consistency will be measured using the Bristol Stool Chart (types 6 and 7)
Histologic remission
\<20 IELs/100 surface epithelial cells and subepithelial collagen band \<10 micrometers in biopsy samples and a reduction in lamina propria inflammation
Histologic response
50% reduction in IEL count or subepithelial collagen band thickness compared to baseline and/or a reduction in lamina propria inflammation
Clinical response
50% reduction in average daily stool frequency for the week prior to final assessment compared to baseline
Patient-reported symptom improvement
Change in the European Microscopic Colitis Activity Index (E-MCAI) and its component items, including stool frequency and consistency (stools per day, solid vs. loose stools, stools of each Bristol Stool chart consistency), stools at night, feeling of a need to pass more stools shortly after a bowel movement, urgency of defecation, leakage, and abdominal pain
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University of Calgary
Lead sponsor
Ferring Pharmaceuticals
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
