Trial Details

Authorised
Basic Information
Clinical ID c3304
Identifier EUCTR2009-010921-38-NL
Trial Title Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:_A Double-blind, Randomized Placebo-controlled Pilot Study_ - CRC chemoprevention in UC
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Ulcerative Colitis and the risk of developing colorectal cancer. MedDRA version: 13.1_Level: PT_Classification code 10021972_Term: Inflammatory bowel disease_System Organ Class: 10017947 - Gastrointestinal disorders_
Interventions Trade Name: Salofalk Pharmaceutical Form: Granules INN or Proposed INN: mesalazine CAS Number: 89-57-6 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 20-25 Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use Trade Name: Ursofalk Pharmaceutical Form: Coated tablet INN or Proposed INN: ursodeoxycholic acid CAS Number: 128-13-2 Concentration unit: g gram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use
Participant Information
Sponsor UMC Utrecht
City -
Country/Region Netherlands
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -