Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 10, 2009
November 15, 2011
December 2009
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01011322 on ClinicalTrials.gov Archive Site
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis [ Time Frame: After study is completed ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ulcerative Colitis
  • Large Intestine
  • Diarrhea
  • Abdominal Pain
  • Drug: LT-02
    Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
  • Drug: placebo
    placebo
  • Experimental: LT-02 Dose 1
    0.2g IMP per dose
    Intervention: Drug: LT-02
  • Experimental: LT-02 Dose 2
    0.4g IMP per dose
    Intervention: Drug: LT-02
  • Experimental: LT-02 Dose 3
    0.8g IMP per dose
    Intervention: Drug: LT-02
  • Placebo Comparator: Sugar pill
    placebo matching to 0g of IMP,
    Intervention: Drug: placebo
Karner M, Kocjan A, Stein J, Schreiber S, von Boyen G, Uebel P, Schmidt C, Kupcinskas L, Dina I, Zuelch F, Keilhauer G, Stremmel W. First multicenter study of modified release phosphatidylcholine "LT-02" in ulcerative colitis: a randomized, placebo-controlled trial in mesalazine-refractory courses. Am J Gastroenterol. 2014 Jul;109(7):1041-51. doi: 10.1038/ajg.2014.104. Epub 2014 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
156
February 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Lithuania,   Romania
 
NCT01011322
LT-02-UC-01, 2008-007952-90
No
Lipid Therapeutics GmbH
Lipid Therapeutics GmbH
Not Provided
Principal Investigator: Max Karner, MD University Clinic Heidelberg, Germany
Lipid Therapeutics GmbH
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP