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

November 15, 2011 updated by: Lipid Therapeutics GmbH
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
Time Frame: From day 1 of treatment until end of treatment
From day 1 of treatment until end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
Time Frame: After study is completed
After study is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lipid Therapeutics GmbH

Investigators

  • Principal Investigator: Max Karner, MD, University Clinic Heidelberg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-02-UC-01
  • 2008-007952-90 (Registry Identifier: EudraCT No.:)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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