Clinical Trial

Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients With Mild to Moderately Active Ulcerative Colitis

Recruiting Phase 2/3
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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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-03; most recent amendment 2026-06-08.
Status change: Not Yet Recruiting → Recruiting 2024-11-04
Trial Details
NCT Number NCT06488625
Lead Sponsor University Hospital Schleswig-Holstein
Collaborators: Gesellschaft für Therapieforschung mbH, Funded by the German Federal Ministry of Research, Technology and Space (01KG2006), Ced Service GmbH
Conditions Ulcerative Colitis, Unspecified
Enrollment 459 participants
Start Date 2024-09-12
Primary Completion 2027-10 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-11