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

Phase 3

Completed

• Conditions: Patients Who Receive Colonoscopy

• Registration Number: JPRN-jRCT2080224608
• Lead Sponsor: ihon Pharmaceutical Co., Ltd

Brief Summary

In subjects undergoing colonoscopy, NPF-08 administered on the day of colonoscopy or in divided doses over 2 days was as effective as Mooviprep administered on the day of colonoscopy. As for the safety, there were no new concerns or clinically relevant events in any treatment groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-22
• Study Completion: 2019-06-19
• Results First Posted: 2021-01-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 602

Inclusion Criteria

1.Japanese men and women aged 20 years or older at obtaining the written informed consent.
2.Patients who require colonoscopy(except for emergency colonoscopy).
3.Patients who have the ability to consent and submit the written informed consent by themselves.

Exclusion Criteria

1.Patients who have or are suspected to have gastrointestinal obstruction.
2.Patients who have or are suspected to have intestinal perforation.
3.Patients who have or are suspected to have toxic megacolon.
4.Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
5.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).
6.Patients with vomiting reflex or in whom accidental ingestion may occur.
7.Patients with a history of gastrointestinal surgery (except for appendicectomy).
8.Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
9.Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
10.Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
11.Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
12.Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
13.Patients with dehydration.
14.Patients who were diagnosed with active inflammatory bowel disease at screening period.
15.Inpatients due to the reasons other than endoscopy large bowel.
16.Patients who have undergone nutritional control using total parenteral nutrition or enteral nutrition.
17.Women who are or may be pregnant, lactating or wish to become pregnant during the trial period.
18.Patients with a history or high-risk of seizure.
19.Patients with a history of shock or hypersensitivity for the active ingredient of the investigational product.
20.Patients who have received the other investigational product within 4 months before the written informed consent or who are participating in the other clinical trials.
21.Patients in whom Investigator/Sub-Investigator decided not to be eligible for this trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified