Trial Details
Not RecruitingBasic Information
| Clinical ID | c3354 |
|---|---|
| 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: Inflammatory bowel disease_ |
| Interventions | Trade Name: Salofalk 4g/60ml Klysma Pharmaceutical Form: Enema* INN or Proposed INN: MESALAZINE CAS Number: 89576 Current Sponsor code: Salofalk 4g/60ml Klysma Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 0,666666- Pharmaceutical form of the placebo: Enema* Route of administration of the placebo: Rectal use |
Participant Information
| Sponsor | CharitUniversitsmedizin, Campus CharitMitte |
|---|---|
| City | - |
| Country/Region | Germany |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | - |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | PHASE2 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | 2022-04-07 |
| Completion Date | 2008-08-31 |