- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00742599
Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-blind, Parallel-assignment , Placebo-controlled Study)
Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20 mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure).
The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration in comparison with the placebo group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Kansai, Japan
-
Kanto, Japan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected upper gastrointestinal disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
- Patients who need gastric endoscopy (except for endoscopy with a scope of <9 mm in diameter, emergency endoscopy and endoscopy for comprehensive medical examination)
- Patients who are older than 20 years at the time of consent
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study. The criteria (2) to (5) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.
- Patients with a history of surgery to the upper gastrointestinal tract
- Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- Patients with upper gastrointestinal bleeding which requires hemostasis
- Patients with reflux esophagitis (Los Angeles classification: B, C or D)
- Patients with gastric or duodenal ulcers in active stage
- Patients on cancer treatment (chemotherapy or radiotherapy)
- Patients with impaired cardiac function (NYHA functional classification: III or IV)
- Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
- Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
- Patients who have been exposed to NPO-11
- Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: P
|
20 ml NPO-11(Placebo)
|
Active Comparator: N
|
20 ml NPO-11
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence or absence of gastric peristalsis (central evaluation by independent evaluator) No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.
Time Frame: each evaluation point
|
each evaluation point
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in gastric peristalsis
Time Frame: each evaluation point
|
each evaluation point
|
Difficulty level of intragastric observation (evaluation by investigator who performs endoscopy)
Time Frame: each evaluation point
|
each evaluation point
|
Adverse events and ADRs observed between administration and 7±3 days after administration
Time Frame: each evaluation point
|
each evaluation point
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NPO-11-01/C-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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