Trial Details

Not Recruiting
Basic Information
Clinical ID c5141
Identifier EUCTR2006-004162-13-DE
Trial Title Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients
Trial URL Visit Original Page
Study Information
Study Results

Yes
Conditions Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohns Disease (Colon) with signs of inflammation within 40 cm ab ano. MedDRA version: 8.1.Level: LLT.Classification code 10021972.Term: Inflammato
Interventions Trade Name: Salofalk 4g/60ml KlysmaPharmaceutical Form: Enema*INN or Proposed INN: MESALAZINECAS Number: 89576Current Sponsor code: Salofalk 4g/60ml KlysmaConcentration unit: g/ml gram(s)/millilitreConcentration type: equal
Participant Information
Sponsor CharitUniversitsmedizin, Campus CharitMitte
City NULL
Country/Region Germany
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement NULL
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE2
Time Information
Start Date NULL
Primary Completion Date NULL
Completion Date NULL