Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 3:34 AM
Study NCT ID:
NCT05915104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: