drugset / Trial / NCT06488625
Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients With Mild to Moderately Active Ulcerative Colitis
Phase 2/3
Recruiting
459 enrolled
University Hospital Schleswig-Holstein
Ced Service GmbH · collabFunded by the German Federal Ministry of Research, Technology and Space (01KG2006) · collabGesellschaft für Therapieforschung mbH · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Double-blind, randomised, placebo-controlled phase II / III trial evaluating efficacy and safety of two different doses (2 g/d or 3 g/d) of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to placebo in patients with ulcerative colitis (UC). The intended therapeutic use of CICR-NAM is to improve intestinal inflammation in adults with UC by topically increasing nicotinamide supply in the ileocolonic region and thus favourably influencing the composition of intestinal microbiota
Timeline
- Start
- 2024-09-12
- Primary completion
- 2027-10
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotinamide | Other / unclassified | 2 g | Oral |
| Subject | Nicotinamide | Other / unclassified | 3 g | Oral |