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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007952-90 | Registry Identifier | EudraCT No.: |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT-02 Dose 1 | Experimental | 0.2g IMP per dose |
|
| LT-02 Dose 2 | Experimental | 0.4g IMP per dose |
|
| LT-02 Dose 3 | Experimental | 0.8g IMP per dose |
|
| Sugar pill | Placebo Comparator | placebo matching to 0g of IMP, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT-02 | Drug | Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis | From day 1 of treatment until end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis | After study is completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Max Karner, MD | University Clinic Heidelberg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterologische Praxis | Baden-Baden | Baden-Wurttemberg | 76530 | Germany | ||
| University Clinic Heidelberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24796768 | Derived | Karner M, Kocjan A, Stein J, Schreiber S, von Boyen G, Uebel P, Schmidt C, Kupcinskas L, Dina I, Zuelch F, Keilhauer G, Stremmel W. First multicenter study of modified release phosphatidylcholine "LT-02" in ulcerative colitis: a randomized, placebo-controlled trial in mesalazine-refractory courses. Am J Gastroenterol. 2014 Jul;109(7):1041-51. doi: 10.1038/ajg.2014.104. Epub 2014 May 6. |
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| placebo | Drug | placebo |
|
| Heidelberg |
| Baden-Wurttemberg |
| 69120 |
| Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | Baden-Wurttemberg | Germany |
| Universitaetsklinikum Ulm | Ulm | Baden-Wurttemberg | 89070 | Germany |
| Gastroenterologische Praxis | Hamburg | Free and Hanseatic City of Hamburg | 20148 | Germany |
| Interdisziplinäres Crohn&Colitis Studienzentrum | Frankfurt am Main | Hesse | 60318 | Germany |
| City Hospital Braunschweig | Braunschweig | Lower Saxony | 38216 | Germany |
| City Hospital Lueneburg | Lüneburg | Lower Saxony | 21339 | Germany |
| Gastroenterologisches Zentrum | Minden | Lower Saxony | 32423 | Germany |
| Internistische Facharztpraxis | Lüdenscheid | Northrine-Westfalia | 58507 | Germany |
| Internistische Gemeinschaftspraxis | Ludwigshafen | Rhineland-Platinate | 67067 | Germany |
| University Clinics des Saarlandes | Homburg/Saar | Saarland | 66421 | Germany |
| UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie, | Leipzig | Saxony | 04103 | Germany |
| Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen | Leipzig | Saxony | 04105 | Germany |
| Universitaetsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitaetsklinikum Jena | Jena | Thuringa | 07743 | Germany |
| Kaunas Medical University Hospital , Department of Endoscopy | Kaunas | Lithuania | 50009 | Lithuania |
| Kaunas Medical University Hospital, Department of Gastroenterology | Kaunas | Lithuania | 50009 | Lithuania |
| Klaipeda Seamen Hospital | Klaipėda | Lithuania | 92288 | Lithuania |
| Siauliai District Hospital | Šiauliai | Lithuania | 76213 | Lithuania |
| Santariskes Clinics Centras | Vilnius | Lithuania | 01102 | Lithuania |
| Clinical Hospital Colentina | Bucharest | Romania | 020125 | Romania |
| SC Endocenter Medicina Integrativa Bucuresti | Bucharest | Romania | 021978 | Romania |
| Cabinet Medical Individual Dr. Tirnaveanu | Oradea | Romania | 410163 | Romania |
| Algomed Policlinic Timisoara | Timișoara | Romania | 300002 | Romania |
| Policlinica Dr. Citu | Timișoara | Romania | 300594 | Romania |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003967 | Diarrhea |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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