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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Lipid Therapeutics GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Lipid Therapeutics GmbH
ClinicalTrials.gov Identifier:
NCT01011322
First received: November 10, 2009
Last updated: November 15, 2011
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Ulcerative Colitis
Large Intestine
Diarrhea
Abdominal Pain
 Drug: LT-02
Drug: placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lipid Therapeutics GmbH:

Primary Outcome Measures:
  • To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis [ Time Frame: From day 1 of treatment until end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis [ Time Frame: After study is completed ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: December 2009
Estimated Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011322

Locations
Germany
Gastroenterologische Praxis
Baden-Baden, Baden-Wuerttemberg, Germany, 76530
University Clinic Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Robert-Bosch-Krankenhaus
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
Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
Leipzig, Saxony, Germany, 04105
UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
Leipzig, Saxony, Germany, 04103
Universitaetsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Universitaetsklinikum Jena
Jena, Thuringa, Germany, 07743
Gastroenterologische Praxis
Hamburg, Germany, 20148
Lithuania
Kaunas Medical University Hospital, Department of Gastroenterology
Kaunas, Lithuania, 50009
Kaunas Medical University Hospital , Department of Endoscopy
Kaunas, Lithuania, 50009
Klaipeda Seamen Hospital
Klaipeda, Lithuania, 92288
Siauliai District Hospital
Siauliai, Lithuania, 76213
Santariskes Clinics Centras
Vilnius, Lithuania, 01102
Romania
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
Investigators
Principal Investigator: Max Karner, MD University Clinic Heidelberg, Germany
  More Information

No publications provided

Responsible Party: Lipid Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT01011322     History of Changes
Other Study ID Numbers: LT-02-UC-01, 2008-007952-90
Study First Received: November 10, 2009
Last Updated: November 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: State Institute for Drug Control

Additional relevant MeSH terms:
Abdominal Pain
Colitis
Colitis, Ulcerative
Diarrhea
Ulcer
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013