A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
- Conditions
- Ulcerative ColitisLarge IntestineDiarrheaAbdominal Pain
- Interventions
- Drug: placebo
- Registration Number
- NCT01011322
- Lead Sponsor
- Lipid Therapeutics GmbH
- Brief Summary
The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 156
- Men and women 18 years or older who have given written Informed Consent
- Patients with proven ulcerative colitis
- Active disease course for the last 6 weeks or longer with bloody diarrhea
- Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine.
- Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
- Crohn's disease,
- Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis,
- Treatment with other investigational medicinal product within 3 months prior to study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LT-02 Dose 1 LT-02 0.2g IMP per dose LT-02 Dose 2 LT-02 0.4g IMP per dose Sugar pill placebo placebo matching to 0g of IMP, LT-02 Dose 3 LT-02 0.8g IMP per dose
- Primary Outcome Measures
Name Time Method To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis From day 1 of treatment until end of treatment
- Secondary Outcome Measures
Name Time Method To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis After study is completed
Trial Locations
- Locations (25)
University Clinics des Saarlandes
🇩🇪Homburg/Saar, Saarland, Germany
Universitaetsklinikum Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany
City Hospital Braunschweig
🇩🇪Braunschweig, Lower Saxony, Germany
Internistische Gemeinschaftspraxis
🇩🇪Ludwigshafen, Rhineland-Platinate, Germany
Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
🇩🇪Leipzig, Saxony, Germany
Cabinet Medical Individual Dr. Tirnaveanu
🇷🇴Oradea, Romania
Policlinica Dr. Citu
🇷🇴Timisoara, Romania
Internistische Facharztpraxis
🇩🇪Luedenscheid, Northrine-Westfalia, Germany
Universitaetsklinikum Jena
🇩🇪Jena, Thuringa, Germany
Kaunas Medical University Hospital , Department of Endoscopy
🇱🇹Kaunas, Lithuania
Klaipeda Seamen Hospital
🇱🇹Klaipeda, Lithuania
University Clinic Heidelberg
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Kaunas Medical University Hospital, Department of Gastroenterology
🇱🇹Kaunas, Lithuania
Siauliai District Hospital
🇱🇹Siauliai, Lithuania
UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
🇩🇪Leipzig, Saxony, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden-Wuerttemberg, Germany
Gastroenterologisches Zentrum
🇩🇪Minden, Lower Saxony, Germany
Santariskes Clinics Centras
🇱🇹Vilnius, Lithuania
Clinical Hospital Colentina
🇷🇴Bucarest, Romania
Algomed Policlinic Timisoara
🇷🇴Timisoara, Romania
Gastroenterologische Praxis
🇩🇪Hamburg, Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Baden-Wuerttemberg, Germany
Interdisziplinäres Crohn&Colitis Studienzentrum
🇩🇪Frankfurt, Hesse, Germany
City Hospital Lueneburg
🇩🇪Lueneburg, Lower Saxony, Germany
SC Endocenter Medicina Integrativa Bucuresti
🇷🇴Bucarest, Romania