Status:
COMPLETED
Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Patients Undergoing Gastrointestinal Endoscopy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03263910
Start Date
August 21 2017
End Date
August 17 2018
Last Update
August 23 2018
Active Locations (4)
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1
East China
East China, China
2
North China, China
3
Northwest China, China
4
South China, China