NCT05915104

Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis

Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis: A Prospective, Randomized, Active Comparator Pilot Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After being informed of the study and potential risks, patients with symptomatically active microscopic colitis who provide written informed consent will undergo a 4-week screening period to determine their eligibility for the study. At week 0, eligible patients will be randomized in a single blind manner (patients will be aware, while investigators will be blinded) in a 1:1 ratio to budesonide MMX (9mg once daily) or budesonide CR (3mg three times daily). The total treatment duration will be for 8 weeks. The primary outcome will be clinical remission, defined by the Hjortswang criteria (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)).

Conditions

• Microscopic Colitis

Interventions

Type	Name	Description
DRUG	Budesonide MMX®	9 mg delayed and extended-release tablet once daily
DRUG	Budesonide controlled ileal release (CR) capsules	three 3 mg capsules daily oral administration for 8 weeks

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-09-01
• Completion: 2026-12-31
• First posted: 2023-06-22
• Last updated: 2023-12-04