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

This study has been completed.
Information provided by:
Nihon Pharmaceutical Co., Ltd Identifier:
First received: August 25, 2008
Last updated: November 8, 2010
Last verified: November 2010

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-blind, Parallel-assignment , Placebo-controlled Study)

Resource links provided by NLM:

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 ]

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

Estimated Enrollment: 80
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N Drug: NPO-11
20 ml NPO-11
Placebo Comparator: P Drug: Placebo
20 ml NPO-11(Placebo)


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  1. Patients who need gastric endoscopy (except for endoscopy with a scope of <9 mm in diameter, emergency endoscopy and endoscopy for comprehensive medical examination)
  2. 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.

  1. Patients with a history of surgery to the upper gastrointestinal tract
  2. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
  3. Patients with upper gastrointestinal bleeding which requires hemostasis
  4. Patients with reflux esophagitis (Los Angeles classification: B, C or D)
  5. Patients with gastric or duodenal ulcers in active stage
  6. Patients on cancer treatment (chemotherapy or radiotherapy)
  7. Patients with impaired cardiac function (NYHA functional classification: III or IV)
  8. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
  9. Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
  10. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  11. Patients who have been exposed to NPO-11
  12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
  13. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
  Contacts and Locations
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Please refer to this study by its identifier: NCT00742599

Kansai, Japan
Kanto, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yasumasa Ogawa, Nihon Pharmaceutical Co., Ltd Identifier: NCT00742599     History of Changes
Other Study ID Numbers: NPO-11-01/C-01
Study First Received: August 25, 2008
Last Updated: November 8, 2010

Keywords provided by Nihon Pharmaceutical Co., Ltd:
Stomach Diseases processed this record on May 23, 2017