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Completed

NCT Number: NCT00742599

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

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.

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Key information

Conditions

Patients Undergoing Gastric Endoscopy Digestive System Diseases Gastrointestinal Diseases Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kansai, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.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

Treatment and study plan

NPO-11

Drug

20 ml NPO-11

Placebo

Drug

20 ml NPO-11(Placebo)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-blind, Parallel-assignment , Placebo-controlled Study)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2008
Registry last updated
Nov 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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