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NCT05915104
Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis
Phase 2 trial testing Budesonide MMX® in Microscopic Colitis in 80 participants. Not yet recruiting.
1 September 2026
Quick facts
| Lead sponsor | University of Calgary |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 January 2024 |
| Primary completion | 1 September 2026 |
| Estimated completion | 31 December 2026 |
Drugs / interventions tested
- Budesonide MMX® — full drug profile →
- Budesonide controlled ileal release (CR) capsules — full drug profile →
Conditions studied
- Microscopic Colitis — all drugs for Microscopic Colitis →
Sponsor
University of Calgary
Who can join
Adults 18 to 80, any sex, with Microscopic Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05915104
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Budesonide MMX®
Trials testing the same drug.
- NCT01532648 — Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulce · Phase 3 · completed
Other recruiting trials for Microscopic Colitis
Currently open trials in the same condition.
- NCT07156175 — A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission · Phase 2 · recruiting
- NCT06530836 — Chronic Diarrhea Owing to Underlying Microscopic Colitis · active not recruiting
Other University of Calgary trials
Trials by the same sponsor.
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- NCT07145645 — Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children · Phase 3 · recruiting
- NCT07280325 — Moxie Self-Management and Education Support Program · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05915104 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Calgary
- Last refreshed: 4 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05915104.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing