First Multicenter Study of Modified Release Phosphatidylcholine "LT-02" in Ulcerative Colitis: A Randomized, Placebo-Controlled Trial in Mesalazine-Refractory Courses

Karner, Max, Kocjan, Andreas, Stein, Juergen, Schreiber, Stefan, von Boyen, Georg, Uebel, Peter, Schmidt, Carsten, Kupcinskas, Limas, Dina, Ion, Zuelch, Frank, Keilhauer, Gerhard and Stremmel, Wolfgang (2014) First Multicenter Study of Modified Release Phosphatidylcholine "LT-02" in Ulcerative Colitis: A Randomized, Placebo-Controlled Trial in Mesalazine-Refractory Courses American Journal of Gastroenterology, 109 (7). pp. 1041-1051.

Full text not available from this repository.

Abstract

OBJECTIVES: Phosphatidylcholine is a key component of the mucosal barrier. Treatment with modified release phosphatidylcholine aims to improve the impaired barrier function. The primary objective is to evaluate the efficacy of LT-02, a newly designed modified release phosphatidylcholine formula, in a multicenter setting. 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. RESULTS: Baseline characteristics and dropouts were well balanced between all groups. The primary analyses revealed an SCCAI drop of 33.3% in the placebo group (from 9.0 to 6.0 points) compared with 44.3% in the 0.8 g LT-02 (from 8.8 to 4.9, P > 0.05) and 40.7 % in the 1.6 g groups (from 8.6 to 5.1, P > 0.05). The 3.2 g group improved 51.7% from 8.5 to 4.1 (P = 0.030 in comparison with placebo). The remission rate was 15% (6 /40) in the placebo group compared with 31.4 % (11 /35) in the highest LT-02 dose group (P = 0.089). Mucosal healing was achieved in 32.5% of placebo patients compared with 47.4% of LT-02 patients (P = 0.098); the rates for histologic remission were 20% compared with 40.5%, respectively (P = 0.016). There were 17 (48.6%) treatment-emergent adverse events in the highest dose group (and 0 serious adverse events (SAEs)) compared with 22 (55%) in the placebo group (4 SAEs). CONCLUSIONS: The primary end point analysis showed a statistically signifi cant improvement in disease activity during LT-02 treatment in comparison with placebo. The drug was found to be very safe.

Document Type: Article
Additional Information: Times Cited: 6 0 6
Research affiliation: Kiel University
OceanRep > The Future Ocean - Cluster of Excellence
ISSN: 0002-9270
Projects: Future Ocean
Date Deposited: 30 Mar 2015 12:27
Last Modified: 30 Mar 2015 12:27
URI: http://eprints.uni-kiel.de/id/eprint/27739

Actions (login required)

View Item View Item