Completed

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

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What is being tested

NPF-08 （1-day treatment）

+ NPF-08 （2-day split dose）

+ Moviprep（1-day treatment）

Drug
Who is being recruted

Over 20 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 3
Interventional
Study Start: January 2019
See protocol details

Summary

Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 5, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy
NCT03794310
Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

632 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Japanese men and women aged 20 years or older at obtaining the written informed consent.
Patients who require colonoscopy (except for emergency colonoscopy)
Patients who have the ability to consent and submit the written informed consent by themselves.
21 exclusion criteria prevent from participating
Patients with intestinal stenosis or high-grade constipation (stool frequency of 2 or less in a week or who have used laxative on a daily basis).
Patients who have or are suspected to have gastrointestinal obstruction.
Patients who have or are suspected to have intestinal perforation.
Patients who have or are suspected to have toxic megacolon.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Suspended

NPF-08 Trial Site 12

Abiko, JapanOpen NPF-08 Trial Site 12 in Google Maps
Suspended

NPF-08 Trial Site 11

Kashiwa, Japan
Suspended

NPF-08 Trial Site 1

Maebashi, Japan
Suspended

NPF-08 Trial Site 10

Kawasaki, Japan
Completed13 Study Centers