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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01011322
Recruitment Status : Unknown
Verified August 2010 by Lipid Therapeutics GmbH.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2009
Last Update Posted : November 16, 2011
Information provided by (Responsible Party):
Lipid Therapeutics GmbH

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Large Intestine Diarrhea Abdominal Pain Drug: LT-02 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : July 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LT-02 Dose 1
0.2g IMP per dose
Drug: LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks

Experimental: LT-02 Dose 2
0.4g IMP per dose
Drug: LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks

Experimental: LT-02 Dose 3
0.8g IMP per dose
Drug: LT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks

Placebo Comparator: Sugar pill
placebo matching to 0g of IMP,
Drug: placebo

Primary Outcome Measures :
  1. To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis [ Time Frame: From day 1 of treatment until end of treatment ]

Secondary Outcome Measures :
  1. To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis [ Time Frame: After study is completed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01011322

Gastroenterologische Praxis
Baden-Baden, Baden-Wuerttemberg, Germany, 76530
University Clinic Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Stuttgart, Baden-Wuerttemberg, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wuerttemberg, Germany, 89070
Interdisziplinäres Crohn&Colitis Studienzentrum
Frankfurt, Hesse, Germany, 60318
City Hospital Braunschweig
Braunschweig, Lower Saxony, Germany, 38216
City Hospital Lueneburg
Lueneburg, Lower Saxony, Germany, 21339
Gastroenterologisches Zentrum
Minden, Lower Saxony, Germany, 32423
Internistische Facharztpraxis
Luedenscheid, Northrine-Westfalia, Germany, 58507
Internistische Gemeinschaftspraxis
Ludwigshafen, Rhineland-Platinate, Germany, 67067
University Clinics des Saarlandes
Homburg/Saar, Saarland, Germany, 66421
UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
Leipzig, Saxony, Germany, 04103
Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
Leipzig, Saxony, Germany, 04105
Universitaetsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Universitaetsklinikum Jena
Jena, Thuringa, Germany, 07743
Gastroenterologische Praxis
Hamburg, Germany, 20148
Kaunas Medical University Hospital , Department of Endoscopy
Kaunas, Lithuania, 50009
Kaunas Medical University Hospital, Department of Gastroenterology
Kaunas, Lithuania, 50009
Klaipeda Seamen Hospital
Klaipeda, Lithuania, 92288
Siauliai District Hospital
Siauliai, Lithuania, 76213
Santariskes Clinics Centras
Vilnius, Lithuania, 01102
Clinical Hospital Colentina
Bucarest, Romania, 020125
SC Endocenter Medicina Integrativa Bucuresti
Bucarest, Romania, 021978
Cabinet Medical Individual Dr. Tirnaveanu
Oradea, Romania, 410163
Algomed Policlinic Timisoara
Timisoara, Romania, 300002
Policlinica Dr. Citu
Timisoara, Romania, 300594
Sponsors and Collaborators
Lipid Therapeutics GmbH
Principal Investigator: Max Karner, MD University Clinic Heidelberg, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lipid Therapeutics GmbH Identifier: NCT01011322     History of Changes
Other Study ID Numbers: LT-02-UC-01
2008-007952-90 ( Registry Identifier: EudraCT No.: )
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: August 2010

Additional relevant MeSH terms:
Colitis, Ulcerative
Abdominal Pain
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases