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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lipid Therapeutics GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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