Phase III General 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:	NCT00745459

Purpose

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

Condition	Intervention	Phase
Stomach Diseases	Drug: NPO-11	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Stomach Disorders

U.S. FDA Resources

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 (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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Study Completion Date:	August 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
N: Experimental 20 mL NPO-11	Drug: NPO-11 20 mL NPO-11

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745459

Locations

Japan

kanto, Japan

kansai, Japan

chubu, Japan

Shikoku, Japan

Sponsors and Collaborators

Nihon Pharmaceutical Co., Ltd

More Information

No publications provided

Responsible Party:	Nihon Pharmaceutical Co., Ltd ( Yasumasa Ogawa )
Study ID Numbers:	NPO-11-01/S-01
Study First Received:	September 1, 2008
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00745459 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nihon Pharmaceutical Co., Ltd:

Patients
undergoing
gastric
endoscopy

Study placed in the following topic categories:

Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 10, 2009