A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
NCT ID: NCT01011322
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
156 participants
INTERVENTIONAL
2009-12-31
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LT-02 Dose 1
0.2g IMP per dose
LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
LT-02 Dose 2
0.4g IMP per dose
LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
LT-02 Dose 3
0.8g IMP per dose
LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
Sugar pill
placebo matching to 0g of IMP,
placebo
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
placebo
placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lipid Therapeutics GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Max Karner, MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic Heidelberg, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gastroenterologische Praxis
Baden-Baden, Baden-Wurttemberg, Germany
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Gastroenterologische Praxis
Hamburg, City state of Hamburg, Germany
Interdisziplinäres Crohn&Colitis Studienzentrum
Frankfurt am Main, Hesse, Germany
City Hospital Braunschweig
Braunschweig, Lower Saxony, Germany
City Hospital Lueneburg
Lüneburg, Lower Saxony, Germany
Gastroenterologisches Zentrum
Minden, Lower Saxony, Germany
Internistische Facharztpraxis
Lüdenscheid, Northrine-Westfalia, Germany
Internistische Gemeinschaftspraxis
Ludwigshafen, Rhineland-Platinate, Germany
University Clinics des Saarlandes
Homburg/Saar, Saarland, Germany
UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
Leipzig, Saxony, Germany
Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Jena
Jena, Thuringa, Germany
Kaunas Medical University Hospital , Department of Endoscopy
Kaunas, Lithuania, Lithuania
Kaunas Medical University Hospital, Department of Gastroenterology
Kaunas, Lithuania, Lithuania
Klaipeda Seamen Hospital
Klaipėda, Lithuania, Lithuania
Siauliai District Hospital
Šiauliai, Lithuania, Lithuania
Santariskes Clinics Centras
Vilnius, Lithuania, Lithuania
Clinical Hospital Colentina
Bucharest, Romania, Romania
SC Endocenter Medicina Integrativa Bucuresti
Bucharest, Romania, Romania
Cabinet Medical Individual Dr. Tirnaveanu
Oradea, Romania, Romania
Algomed Policlinic Timisoara
Timișoara, Romania, Romania
Policlinica Dr. Citu
Timișoara, Romania, Romania
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-007952-90
Identifier Type: REGISTRY
Identifier Source: secondary_id
LT-02-UC-01
Identifier Type: -
Identifier Source: org_study_id