NCT03794310

Study of NPF-08 in Patients Who Receive Colonoscopy

A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 632 (actual)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients Who Receive Colonoscopy

Interventions

Type	Name	Description
DRUG	NPF-08 （1-day treatment）	NPF-08 will be administered on the day of colonoscopy.
DRUG	NPF-08 （2-day split dose）	NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.
DRUG	Moviprep（1-day treatment）	Moviprep will be administered on the day of colonoscopy.

Timeline

• Start date: 2019-01-05
• Primary completion: 2019-06-19
• Completion: 2019-06-19
• First posted: 2019-01-07
• Last updated: 2022-11-29

Locations

13 sites across 1 country: Japan