A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
2 other identifiers
interventional
156
3 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 16, 2011
August 1, 2010
1.6 years
November 10, 2009
November 15, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
From day 1 of treatment until end of treatment
Secondary Outcomes (1)
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
After study is completed
Study Arms (4)
LT-02 Dose 1
EXPERIMENTAL0.2g IMP per dose
LT-02 Dose 2
EXPERIMENTAL0.4g IMP per dose
LT-02 Dose 3
EXPERIMENTAL0.8g IMP per dose
Sugar pill
PLACEBO COMPARATORplacebo matching to 0g of IMP,
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Gastroenterologische Praxis
Baden-Baden, Baden-Wurttemberg, 76530, Germany
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89070, Germany
Gastroenterologische Praxis
Hamburg, 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
Related Publications (1)
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.
PMID: 24796768DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Max Karner, MD
University Clinic Heidelberg, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 11, 2009
Study Start
December 1, 2009
Primary Completion
July 1, 2011
Study Completion
February 1, 2012
Last Updated
November 16, 2011
Record last verified: 2010-08