Back to resultsPhase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
Primary Purpose
Stomach Diseases
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
NPO-11
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Diseases focused on measuring Patients, undergoing, gastric, endoscopy
Eligibility Criteria
Inclusion Criteria:
Inpatients or outpatients of either sex who meet 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 require gastric endoscopy (except for emergency endoscopy or 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) and (3) 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 Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.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 stomach
- Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- Patients with upper gastrointestinal bleeding which requires hemostasis
- Patients on cancer treatment (chemotherapy or radiotherapy)
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
N
Arm Description
20 mL NPO-11
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in gastric peristalsis (central evaluation by independent evaluator) Difficulty level of intragastric observation (evaluation by investigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Full Information
NCT ID
NCT00745459
First Posted
September 1, 2008
Last Updated
November 8, 2010
Sponsor
Nihon Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00745459
Brief Title
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
Official Title
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nihon Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients who require gastric endoscopy, including the patient population* excluded from the phase III controlled clinical study of NPO-11, will receive an intragastric single dose of NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated 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.
Patient population excluded from the phase III controlled clinical study of NPO-11
Patients with reflux esophagitis
Patients with active gastric or duodenal ulcers
Patients who undergo endoscopy under sedation
Patients who undergo endoscopy with a scope of <9 mm in diameter
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Diseases
Keywords
Patients, undergoing, gastric, endoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N
Arm Type
Experimental
Arm Description
20 mL NPO-11
Intervention Type
Drug
Intervention Name(s)
NPO-11
Intervention Description
20 mL NPO-11
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in gastric peristalsis (central evaluation by independent evaluator) Difficulty level of intragastric observation (evaluation by investigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Time Frame
each evaluation point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients or outpatients of either sex who meet 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 require gastric endoscopy (except for emergency endoscopy or 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) and (3) 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 stomach
Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
Patients with upper gastrointestinal bleeding which requires hemostasis
Patients on cancer treatment (chemotherapy or radiotherapy)
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
Facility Information:
City
Chubu
Country
Japan
City
Kansai
Country
Japan
City
Kanto
Country
Japan
City
Shikoku
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
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