Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

Summary

The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)

Timeline

Start

2014-10-01

Primary completion

2018-10-05

Completion

2018-10-05

Publications

• Dignass A, Stremmel W, Horynski M, Poyda O, Armerding P, Fellermann K, Langhorst J, Kuehbacher T, Uebel P, Stein J, Novacek G, Avalueva E, Oliinyk O, Hasselblatt P, Dorofeyev A, Heinemann H, Mueller R, Greinwald R, Reinisch W; International PROTECT-1/2 Study Groups. Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials. Clin Gastroenterol Hepatol. 2024 Apr;22(4):810-820.e7. doi: 10.1016/j.cgh.2023.09.031. Epub 2023 Oct 6.

Drugs

Indications