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

Last updated: November 15, 2011
Sponsor: Lipid Therapeutics GmbH
Overall Status: Trial Status Unknown

Phase

2

Condition

Hyponatremia

Ulcerative Colitis (Pediatric)

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT01011322
LT-02-UC-01
2008-007952-90
  • Ages > 18
  • All Genders

Study 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

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 documentedintolerance to mesalazine.

Exclusion

Exclusion Criteria:

  • Infectious colitis, including cytomegalovirus or Clostridium difficile inducedcolitis,

  • 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 studyentry

Study Design

Total Participants: 156
Study Start date:
December 01, 2009
Estimated Completion Date:
February 29, 2012

Connect with a study center

  • Gastroenterologische Praxis

    Baden-Baden, Baden-Wuerttemberg 76530
    Germany

    Site Not Available

  • University Clinic Heidelberg

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus

    Stuttgart, Baden-Wuerttemberg
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wuerttemberg 89070
    Germany

    Site Not Available

  • Interdisziplinäres Crohn&Colitis Studienzentrum

    Frankfurt, Hesse 60318
    Germany

    Site Not Available

  • City Hospital Braunschweig

    Braunschweig, Lower Saxony 38216
    Germany

    Site Not Available

  • City Hospital Lueneburg

    Lueneburg, Lower Saxony 21339
    Germany

    Site Not Available

  • Gastroenterologisches Zentrum

    Minden, Lower Saxony 32423
    Germany

    Site Not Available

  • Internistische Facharztpraxis

    Luedenscheid, Northrine-Westfalia 58507
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis

    Ludwigshafen, Rhineland-Platinate 67067
    Germany

    Site Not Available

  • University Clinics des Saarlandes

    Homburg/Saar, Saarland 66421
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen

    Leipzig, Saxony 04105
    Germany

    Site Not Available

  • UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,

    Leipzig, Saxony 04103
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Jena

    Jena, Thuringa 07743
    Germany

    Site Not Available

  • Gastroenterologische Praxis

    Hamburg, 20148
    Germany

    Site Not Available

  • Kaunas Medical University Hospital , Department of Endoscopy

    Kaunas, 50009
    Lithuania

    Site Not Available

  • Kaunas Medical University Hospital, Department of Gastroenterology

    Kaunas, 50009
    Lithuania

    Site Not Available

  • Klaipeda Seamen Hospital

    Klaipeda, 92288
    Lithuania

    Site Not Available

  • Siauliai District Hospital

    Siauliai, 76213
    Lithuania

    Site Not Available

  • Santariskes Clinics Centras

    Vilnius, 01102
    Lithuania

    Site Not Available

  • Clinical Hospital Colentina

    Bucarest, 020125
    Romania

    Site Not Available

  • SC Endocenter Medicina Integrativa Bucuresti

    Bucarest, 021978
    Romania

    Site Not Available

  • Cabinet Medical Individual Dr. Tirnaveanu

    Oradea, 410163
    Romania

    Site Not Available

  • Algomed Policlinic Timisoara

    Timisoara, 300002
    Romania

    Site Not Available

  • Policlinica Dr. Citu

    Timisoara, 300594
    Romania

    Site Not Available

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