Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy - Full Text View

Sponsored by:	Nihon Pharmaceutical Co., Ltd
Information provided by:	Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT00742599

Purpose

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.

Condition	Intervention	Phase
Patients Undergoing Gastric Endoscopy	Drug: NPO-11 Drug: Placebo	Phase III

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-Blind, Parallel-Assignment , Placebo-Controlled Study)

Further study details as provided by Nihon Pharmaceutical Co., Ltd:

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. [ Time Frame: each evaluation point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in gastric peristalsis [ Time Frame: each evaluation point ] [ Designated as safety issue: Yes ]
Difficulty level of intragastric observation (evaluation by investigator who performs endoscopy) [ Time Frame: each evaluation point ] [ Designated as safety issue: Yes ]
Adverse events and ADRs observed between administration and 7±3 days after administration [ Time Frame: each evaluation point ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	September 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
N: Active Comparator	Drug: NPO-11 20 ml NPO-11
P: Placebo Comparator	Drug: Placebo 20 ml NPO-11(Placebo)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742599

Locations

Japan

kanto, Japan

kansai, Japan

Sponsors and Collaborators

Nihon Pharmaceutical Co., Ltd

More Information

Responsible Party:	Nihon Pharmaceutical Co., Ltd ( Yasumasa Ogawa )
Study ID Numbers:	NPO-11-01/C-01
Study First Received:	August 25, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00742599
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nihon Pharmaceutical Co., Ltd:

Stomach Diseases

Study placed in the following topic categories:

Stomach Diseases

ClinicalTrials.gov processed this record on January 16, 2009