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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742599
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : November 9, 2010
Information provided by:
Nihon Pharmaceutical Co., Ltd

Brief Summary:

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 or disease Intervention/treatment Phase
Patients Undergoing Gastric Endoscopy Drug: NPO-11 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : September 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: N Drug: NPO-11
20 ml NPO-11
Placebo Comparator: P Drug: Placebo
20 ml NPO-11(Placebo)

Primary Outcome Measures :
  1. 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 :
  1. Change in gastric peristalsis [ Time Frame: each evaluation point ]
  2. Difficulty level of intragastric observation (evaluation by investigator who performs endoscopy) [ Time Frame: each evaluation point ]
  3. Adverse events and ADRs observed between administration and 7±3 days after administration [ Time Frame: each evaluation point ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742599

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

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
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by Nihon Pharmaceutical Co., Ltd:
Stomach Diseases