Study of NPF-08 in Patients Who Receive Colonoscopy

Summary

To study non-inferiority of intestinal cleansing effect in both NPF-08 1-day treatment group and NPF-08 2-day split dose group to the cleansing effect in Moviprep® 1-day treatment group, for the subjects who will receive endoscopy large bowel. If the non-inferiority will be validated, superiority of intestinal cleansing effect in both groups of NPF-08 will be studied. Furthermore, for the assessment of safety of NPF-08, the adverse events and adverse drug reactions observed after the administration to post-examination period will be studied, compared to those at Moviprep® 1-day treatment group.

Timeline

Start

2019-01-05

Primary completion

2019-06-19

Completion

2019-06-19

Publications

• Saito Y, Oka S, Tamai N, Kudo T, Kuniyoshi N, Shirakura T, Omae Y, Hamahata Y, Arai T, Tanaka S, Uedo N, Shimizu S, Fukuzawa M, Uraoka T, Ichinose S, Ogata H, Kobayashi K, Saito S, Tajiri H. Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study. Dig Endosc. 2021 Nov;33(7):1131-1138. doi: 10.1111/den.13930. Epub 2021 Mar 9.

Drugs

Indications

No indication recorded.