A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01011322
• Other study ID #: LT-02-UC-01
• Secondary ID: 2008-007952-90
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 10, 2009
• Last updated: November 15, 2011
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: August 2010
• Source: Lipid Therapeutics GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesLithuania: State Medicine Control Agency - Ministry of HealthRomania: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Colitis
• Colitis, Ulcerative
• Diarrhea
• Large Intestine
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
• placebo
placebo

Locations

Country	Name	City	State
Germany	Gastroenterologische Praxis	Baden-Baden	Baden-Wuerttemberg
Germany	City Hospital Braunschweig	Braunschweig	Lower Saxony
Germany	Interdisziplinäres Crohn&Colitis Studienzentrum	Frankfurt	Hesse
Germany	Gastroenterologische Praxis	Hamburg
Germany	University Clinic Heidelberg	Heidelberg	Baden-Wuerttemberg
Germany	University Clinics des Saarlandes	Homburg/Saar	Saarland
Germany	Universitaetsklinikum Jena	Jena	Thuringa
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen	Leipzig	Saxony
Germany	UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,	Leipzig	Saxony
Germany	Internistische Gemeinschaftspraxis	Ludwigshafen	Rhineland-Platinate
Germany	Internistische Facharztpraxis	Luedenscheid	Northrine-Westfalia
Germany	City Hospital Lueneburg	Lueneburg	Lower Saxony
Germany	Gastroenterologisches Zentrum	Minden	Lower Saxony
Germany	Robert-Bosch-Krankenhaus	Stuttgart	Baden-Wuerttemberg
Germany	Universitaetsklinikum Ulm	Ulm	Baden-Wuerttemberg
Lithuania	Kaunas Medical University Hospital , Department of Endoscopy	Kaunas
Lithuania	Kaunas Medical University Hospital, Department of Gastroenterology	Kaunas
Lithuania	Klaipeda Seamen Hospital	Klaipeda
Lithuania	Siauliai District Hospital	Siauliai
Lithuania	Santariskes Clinics Centras	Vilnius
Romania	Clinical Hospital Colentina	Bucarest
Romania	SC Endocenter Medicina Integrativa Bucuresti	Bucarest
Romania	Cabinet Medical Individual Dr. Tirnaveanu	Oradea
Romania	Algomed Policlinic Timisoara	Timisoara
Romania	Policlinica Dr. Citu	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
Lipid Therapeutics GmbH

Countries where clinical trial is conducted

Germany,  Lithuania,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis		From day 1 of treatment until end of treatment	No
Secondary	To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis		After study is completed	No