Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients Undergoing Gastrointestinal Endoscopy

Intervention / Treatment
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* Drug: NPO-11
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPO-11<br> | Drug: NPO-11<br>* 20 ml NPO-11<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 20 ml NPO-11(Placebo)<br>|

What is the study measuring?
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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 |