Clinical trial NCT01011322: A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ulcerative Colitis
Large Intestine
Diarrhea
Abdominal Pain
Lead sponsor: Lipid Therapeutics GmbH
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
timeFrame: From day 1 of treatment until end of treatment
Secondary outcomes:
measure: To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
timeFrame: After study is completed
Other outcomes:
Locations:
city: Baden-Baden
country: Germany
facility: Gastroenterologische Praxis
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-Wuerttemberg
city: Frankfurt
country: Germany
facility: Interdisziplinäres Crohn&Colitis Studienzentrum
state: Hesse
city: Braunschweig
country: Germany
facility: City Hospital Braunschweig
state: Lower Saxony
city: Lueneburg
country: Germany
facility: City Hospital Lueneburg
state: Lower Saxony
city: Minden
country: Germany
facility: Gastroenterologisches Zentrum
state: Lower Saxony
city: Luedenscheid
country: Germany
facility: Internistische Facharztpraxis
state: Northrine-Westfalia
city: Ludwigshafen
country: Germany
facility: Internistische Gemeinschaftspraxis
state: Rhineland-Platinate
city: Homburg/Saar
country: Germany
facility: University Clinics des Saarlandes
state: Saarland
city: Leipzig
country: Germany
facility: UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
state: Saxony
city: Leipzig
country: Germany
facility: Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
state: Saxony
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thuringa
city: Hamburg
country: Germany
facility: Gastroenterologische Praxis
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital , Department of Endoscopy
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital, Department of Gastroenterology
city: Klaipeda
country: Lithuania
facility: Klaipeda Seamen Hospital
city: Siauliai
country: Lithuania
facility: Siauliai District Hospital
city: Vilnius
country: Lithuania
facility: Santariskes Clinics Centras
city: Bucarest
country: Romania
facility: Clinical Hospital Colentina
city: Bucarest
country: Romania
facility: SC Endocenter Medicina Integrativa Bucuresti
city: Oradea
country: Romania
facility: Cabinet Medical Individual Dr. Tirnaveanu
city: Timisoara
country: Romania
facility: Algomed Policlinic Timisoara
city: Timisoara
country: Romania
facility: Policlinica Dr. Citu
Study officials:
affiliation: University Clinic Heidelberg, Germany
name: Max Karner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.