First multicenter study of modified release phosphatidylcholine "LT-02" in ulcerative colitis: a randomized, placebo-controlled trial in mesalazine-refractory courses.

"Guarantor of the article: Max Karner, MD.: Specific author contributions: M.K. was the principal investigator of the study; he helped in the planning and conduct of the trial and prepared the manuscript; he had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. A.K., J.S., S.S., G.v.B., P.U., C.S., L.K., and I.D. were the site investigators of the most active study centers. F.Z. and G.K. are representatives of Lipid Therapeutics (sponsor), Heidelberg, Germany, and helped in the planning and organization of the study. W.S. is the inventor of mrPC; he helped in the study design and prepared the manuscript together with M.K.: Financial support: Lipid Therapeutics (Heidelberg, Germany) is the sponsor of the study and financed the conduct of the study, the CRO, the second statistician, as well as the Data Monitoring Committee. The investigators themselves did not receive money from the sponsor, but the study centers were reimbursed for their work with patients. The study sponsor helped plan the study design and financed the CRO. The CRO, but not the sponsor, managed the conduct of the study, performed the study analyses, and interpreted the data. The sponsor was neither involved in the data collection nor in the preparation of the manuscript.: Potential competing interests: M.K. was reimbursed for his costs to present the study data at a national and an international congress. A.K., J.S., S.S., G.B., P.U., C.S., L.K., and I.D. had no potential conflict of interest. F.Z. and G.K. are representatives of the sponsor. The adult and independent children of W.S. hold the patent for modified release phosphatidylcholine. W.S., F.Z., and G.K. were not involved in patient recruitment, conduct, or analyses of the study. Moreover, F.Z. and G.K., as representatives of the sponsor, were not involved in the preparation, review, or approval of the manuscript, nor in the decision to submit the manuscript for publication."

"Financial support: Lipid Therapeutics (Heidelberg, Germany) is the sponsor of the study and financed the conduct of the study, the CRO, the second statistician, as well as the Data Monitoring Committee. The investigators themselves did not receive money from the sponsor, but the study centers were reimbursed for their work with patients. The study sponsor helped plan the study design and financed the CRO. The CRO, but not the sponsor, managed the conduct of the study, performed the study analyses, and interpreted the data. The sponsor was neither involved in the data collection nor in the preparation of the manuscript."

"METHODS:: This is a double-blinded, randomized, placebo-controlled, superiority study conducted in 24 ambulatory referral centers in Germany, Lithuania, and Romania. A total of 156 patients with an inadequate response to mesalazine, a disease activity score (Simple Clinical Colitis Activity Index (SCCAI)) of ≥5, and bloody diarrhea underwent treatment with 0, 0.8, 1.6, or 3.2 g LT-02. The primary end point was defined a priori as changes in SCCAI from baseline to the end of treatment. The primary statistical model was a general linear least-squares model. The study was funded by the sponsor Lipid Therapeutics, Heidelberg, Germany, and registered at http://clinicaltrials.gov/show/NCT01011322."