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Study of NPF-08 in Patients Who Receive Colonoscopy

NCT03794310 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2022-11-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nihon Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hisatsugu Asada · Nihon Pharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-05
Primary Completion
2019-06-19
Completion
2019-06-19

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794310 on ClinicalTrials.gov