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

NCT06488625 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2024-11-06

No results posted yet for this study

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

Conditions

  • Ulcerative Colitis, Unspecified

Interventions

DRUG

Low-Dose CICR-NAM

2 g/d CICR-NAM (blinded)

DRUG

High-Dose CICR-NAM

3 g/d CICR-NAM (blinded)

DRUG

0 g/d CICR-NAM (blinded)

Placebo (blinded)

DRUG

Open-Label

3 g/d CICR-NAM (open label)

Sponsors & Collaborators

  • Ced Service GmbH

    collaborator OTHER

  • Gesellschaft für Therapieforschung mbH

    collaborator INDUSTRY

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Stefan Schreiber, Prof. Dr. Dr. hc. · University Medical Center Schleswig-Holstein (UKSH) Campus Kiel, Arnold-Heller-Str. 3, 24105 Kiel

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
2024-09-12
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

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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 NCT06488625 on ClinicalTrials.gov