Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy

Summary

Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients having no gastric peristalsis. The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions observed between informed consent and 7 days after administration in comparison with the placebo group.

Timeline

Start

2017-08-21

Primary completion

2018-08-10

Completion

2018-08-17

Publications

• Meng F, Li W, Zhi F, Li Z, Xue Z, He S, Chen W, Chen Y, Xing X, Yao C, Wu Y, Zhang S. Antiperistaltic effect and safety of l-menthol oral solution on gastric mucosa for upper gastrointestinal endoscopy in Chinese patients: Phase III, multicenter, randomized, double-blind, placebo-controlled study. Dig Endosc. 2021 Nov;33(7):1110-1119. doi: 10.1111/den.13941. Epub 2021 Apr 2.

Drugs

Indications

No indication recorded.