Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopi… (NCT05915104) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis
80 participantsStarted 2024-01-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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
* Colonoscopy or flexible sigmoidoscopy with histologically confirmed MC, defined by signs of inflammation of the lamina propria and either:
* lymphocytic colitis: ≥20 IELs/100 surface epithelial cells
* collagenous colitis: subepithelial collagen band \>10 micrometers in diameter
* Ability of subject to participate fully in all aspects of this clinical trial
* Written informed consent must be obtained and documented
Exclusion Criteria:
* 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, ulcerativ…