Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

"Conflict of interest Kentaro Sugano received research grants from Takeda, Astellas, and Schering-Plough, fees for advisory board from Takeda and AstraZeneca, and a lecture fee from Takeda. Kiyoshi Ashida received fee for advisory board from Takeda, and lecture fee from Takeda and Eisai. Masahiro Asaka received a research grant and a lecture fee from Takeda. Tetsuya Kanto received a fee for advisory board from Takeda. Satoshi Soen received research grants from Takeda and Eisai, and a lecture fee from Takeda. Tsutomu Takeuchi received research grants from Takeda, Eisai, and Tanabe-Mitsubishi, and a lecture fee from Tanabe-Mitsubishi. Hideyuki Hiraishi received research grants from Takeda and Ajinomoto, and a lecture fee from Takeda."

"Grant support by Takeda Pharmaceutical Company Limited."

"The Independent Data Monitoring Committee planned an interim analysis in advance to investigate whether or not to continue the study in light of interim efficacy and safety findings, based on the predefined criteria. However, the Independent Data Monitoring Committee recommended discontinuing this trial based on the final results of a companion trial of lansoprazole for prevention of gastric or duodenal ulcers associated with LDA therapy, which showed strong efficacy of low-dose lansoprazole []. After the Committee made the decision to discontinue the double-blind trial, the patients in the 47 healthcare institutions were invited to move on to the follow-up study with open-label lansoprazole treatment lasting up to 6 months. This trial was registered with ClinicalTrials.gov (number NCT00787254)."