Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy

Phase Ⅲ Placebo-controlled Study of NPO-11 in Chinese Patients Undergoing Gastrointestinal Endoscopy

Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients having no gastric peristalsis.

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions observed between informed consent and 7 days after administration in comparison with the placebo group.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Gastrointestinal Endoscopy
• Intervention / Treatment: Drug: NPO-11; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • East China, China
    • East China
  • North China, China
  • Northwest China, China
  • South China, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who are capable of understanding and complying with protocol requirements in the opinion of the investigator or the sub-investigator.
2. Patients who are able to fill in the informed consent form.
3. Patients who require gastrointestinal endoscopy using a scope of 9mm or greater diameter for follow-up of confirmed or investigation of a suspected upper gastrointestinal disease. (except for transnasal endoscopy and emergency endoscopy)
4. Male or female chinese patients aged _18_ to _80
5. Patients who agree to use routinely adequate contraception from signing of informed consent to follow-up.

Exclusion Criteria:

1. Patients have received any investigational drug of other study within 120 days prior to providing their informed consent.
2. Patients had been administered NPO-11 in the past.
3. Patients who are the study site investigator or sub-investigator, an immediate family member (eg, spouse,parent, child, sibling), or may consent under duress.
4. Patients have a history of upper gastrointestinal tract surgery.
5. Patients have gastric stenosis or deformity that would make observation of peristaltic movement difficult.
6. Patients have bleeding in the upper gastrointestinal tract and require hemostatic intervention.
7. Patients have reflux esophagitis (defined as Los Angeles Class: B, C or D)
8. Patients have an active gastric or duodenal ulcer (defined as Sakita-Miwa class: A1 or A2)
9. Patients are on treatment (radiotherapy or chemotherapy) for cancer.
10. Patient have decreased heart function (NYHA heart function class: III or more)
11. Patients have a history of shock, hypersensitivity or allergies to l-menthol or peppermint oil.
12. Patients have a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 12 months prior to the screening visit.
13. Patients are required to take excluded medications.
14. If female, patients are pregnant or lactating or intending to become pregnant from signing of informed consent to follow-up.
15. Any subject who, in the opinion of the investigator or the sub-investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 20 ml NPO-11(Placebo)
Experimental: NPO-11	Drug: NPO-11; 20 ml NPO-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients had no gastric peristalsis during the procedures	No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.(central evaluation by independent evaluator)	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peristaltic movement	The measure use peristaltic grade(central evaluation by independent evaluator).	15 minutes
Difficulty level of intra-gastric observation	Subjective evaluation by investigator or subinvestigator who performs endoscopy	15 minutes
Correlation between the time from the dose to the end of endoscopy and peristaltic grade		15 minutes

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Publications and helpful links

General Publications

• Meng F, Li W, Zhi F, Li Z, Xue Z, He S, Chen W, Chen Y, Xing X, Yao C, Wu Y, Zhang S. Antiperistaltic effect and safety of l-menthol oral solution on gastric mucosa for upper gastrointestinal endoscopy in Chinese patients: Phase III, multicenter, randomized, double-blind, placebo-controlled study. Dig Endosc. 2021 Nov;33(7):1110-1119. doi: 10.1111/den.13941. Epub 2021 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 17, 2018

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NPO-11_301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No