NCT03794310

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

January 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed
Last Updated

November 29, 2022

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

January 4, 2019

Last Update Submit

November 27, 2022

Conditions

Patients Who Receive Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).

    The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective. 1. Almost no residue is found in the intestinal tract enabling good observation 2. Residue remains but does not interfere the observation 3. Residue interferes the observation 4. A lot of residue makes unable to observe 5. Unable to evaluate

    1day

Secondary Outcomes (8)

  • The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists

    1day

  • Colon cleansing effect by site

    1day

  • Evaluation based on Ottawa Bowel Preparation Scale

    1day

  • Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.

    1day

  • Dosage of the investigational product.

    1day or 2day

  • +3 more secondary outcomes

Study Arms (3)

NPF-08 （1-day treatment）

EXPERIMENTAL
Drug: NPF-08 （1-day treatment）

NPF-08 （2-day split dose）

EXPERIMENTAL
Drug: NPF-08 （2-day split dose）

Moviprep（1-day treatment）

ACTIVE COMPARATOR
Drug: Moviprep（1-day treatment）

Interventions

NPF-08 （1-day treatment）DRUG

NPF-08 will be administered on the day of colonoscopy.

NPF-08 （1-day treatment）
NPF-08 （2-day split dose）DRUG

NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.

NPF-08 （2-day split dose）
Moviprep（1-day treatment）DRUG

Moviprep will be administered on the day of colonoscopy.

Moviprep（1-day treatment）

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
  • 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 with vomiting reflex or in whom accidental ingestion may occur.
  • Patients with a history of gastrointestinal surgery (except for appendicectomy).
  • Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
  • Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
  • Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
  • Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
  • Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
  • Patients with dehydration.
  • Patients who were diagnosed with active inflammatory bowel disease at screening period.
  • Inpatients due to the reasons other than endoscopy large bowel.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

NPF-08 Trial Site 12

Abiko, Chiba, Japan

Location

NPF-08 Trial Site 11

Kashiwa, Chiba, Japan

Location

NPF-08 Trial Site 1

Maebashi, Gunnma, Japan

Location

NPF-08 Trial Site 10

Kawasaki, Kanagawa, Japan

Location

NPF-08 Trial Site 5

Yokohama, Kanagawa, Japan

Location

NPF-08 Trial Site 9

Yokohama, Kanagawa, Japan

Location

NPF-08 Trial Site 2

Chuo-Ku, Tokyo, Japan

Location

NPF-08 Trial Site 3

Minato-Ku, Tokyo, Japan

Location

NPF-08 Trial Site 4

Shinjuku-Ku, Tokyo, Japan

Location

NPF-08 Trial Site 8

Hiroshima, Japan

Location

NPF-08 Trial Site 13

Kouchi, Japan

Location

NPF-08 Trial Site 6

Osaka, Japan

Location

NPF-08 Trial Site 7

Osaka, Japan

Location

Related Publications (1)

  • 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.

    PMID: 33476415DERIVED

Study Officials

  • Hisatsugu Asada

    Nihon Pharmaceutical Co., Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 7, 2019

Study Start

January 5, 2019

Primary Completion

June 19, 2019

Study Completion

June 19, 2019

Last Updated

November 29, 2022

Record last verified: 2019-08

Locations

JP(13)