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

NCT05915104 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-12-04

No results posted yet for this study

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.

Conditions

  • Microscopic Colitis

Interventions

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

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Christopher Ma, MD MPH · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-09-01
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05915104 on ClinicalTrials.gov