A Phase 2/3 interventional study of Mesalamine in Microscopic Colitis and Diarrhea, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-24.
Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Treatment
Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects that show improvement will be followed for 4 weeks post medication.
We propose a prospective, randomized trial of mesalamine at 1.2g and 4.8g doses for the treatment of microscopic colitis. Our hypothesis is mesalamine is safe and effective for the treatment of diarrhea in microscopic colitis and that the 4.8g dose is more effective than the 1.2g dose.
We will recruit 70 subjects. The subjects will be randomized into to two groups, 4.8g dose, and 1.2g dose groups. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Responders will be followed for 4 weeks post medication.
Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Subjects will be excluded if they have unsuccessful treatment or side effects to 5-ASA drugs, oral corticosteroids, or salicylate. and antibiotics, mesalamine, bismuth or steroid use in the last two weeks. Subjects may not be on anticholinergics, cholestyramine, digoxin. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions.
A two-sample z-score test for proportions will be used to test whether relief rates are different between groups.
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
This study's enrollment of 70 is above the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.
Browse Colitis, Microscopic studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To determine the efficacy of mesalamine at 1.2g and 4.8g doses in microscopic colitis for providing relief of diarrhea
To compare the safety and tolerability of mesalamine at 1.2g and 4.8g doses in patients with microscopic colitis.
The record gives a start of Feb 2007, a primary completion of Nov 2007 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mesalamine