Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy

NCT03263910 | Completed Phase 3

• 1 other identifier: NPO-11_301
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Patients Undergoing Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in peristaltic movement

  15 minutes

• Difficulty level of intra-gastric observation

  15 minutes

• Correlation between the time from the dose to the end of endoscopy and peristaltic grade

  15 minutes

Study Arms (2)

NPO-11

EXPERIMENTAL

Drug: NPO-11

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NPO-11 DRUG

20 ml NPO-11

NPO-11

Placebo DRUG

20 ml NPO-11(Placebo)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are capable of understanding and complying with protocol requirements in the opinion of the investigator or the sub-investigator.
• Patients who are able to fill in the informed consent form.
• 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)
• Male or female chinese patients aged \_18\_ to \_80
• Patients who agree to use routinely adequate contraception from signing of informed consent to follow-up.

You may not qualify if:

• Patients have received any investigational drug of other study within 120 days prior to providing their informed consent.
• Patients had been administered NPO-11 in the past.
• Patients who are the study site investigator or sub-investigator, an immediate family member (eg, spouse,parent, child, sibling), or may consent under duress.
• Patients have a history of upper gastrointestinal tract surgery.
• Patients have gastric stenosis or deformity that would make observation of peristaltic movement difficult.
• Patients have bleeding in the upper gastrointestinal tract and require hemostatic intervention.
• Patients have reflux esophagitis (defined as Los Angeles Class: B, C or D)
• Patients have an active gastric or duodenal ulcer (defined as Sakita-Miwa class: A1 or A2)
• Patients are on treatment (radiotherapy or chemotherapy) for cancer.
• Patient have decreased heart function (NYHA heart function class: III or more)
• Patients have a history of shock, hypersensitivity or allergies to l-menthol or peppermint oil.
• 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.
• Patients are required to take excluded medications.
• If female, patients are pregnant or lactating or intending to become pregnant from signing of informed consent to follow-up.
• 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.

Sponsors & Collaborators

• Nihon Pharmaceutical Co., Ltd: lead

Study Sites (4)

East China

East China, China

Location

Unknown Facility

North China, China

Location

Unknown Facility

Northwest China, China

Location

Unknown Facility

South China, China

Location

Related Publications (1)

• 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.

  PMID: 33527576 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 28, 2017
• Study Start: August 21, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 17, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

CN (4)