Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer

Summary

This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.

Timeline

Start

2015-05

Primary completion

2018-01

Completion

2018-01

Outcome

Met primary endpoint

paper Compared with the placebo group, odds ratios for gallstone formation were 0.27 (95% CI, 0.12-0.62; P = .002) in the 300-mg group PMID 32584935 ↗

paper and 0.20 (95% CI, 0.08-0.50; P < .001) in the 600-mg group. PMID 32584935 ↗

Publications

• Lee SH, Jang DK, Yoo MW, Hwang SH, Ryu SY, Kwon OK, Hur H, Man Yoon H, Eom BW, Ahn HS, Son T, Song KY, Lee HH, Choi MG, An JY, Lee SI, Lee KH, Ahn S, Park YS, Park DJ; Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study (PEGASUS-D) Group. Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):703-711. doi: 10.1001/jamasurg.2020.1501.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DWJ1319	Unknown	300 mg	Oral
Subject	DWJ1319	Unknown	600 mg	Oral

Indications