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Completed

NCT Number: NCT01411176

Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.

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

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nihon Pharmaceutical Co., Ltd

Tokyo, 101-0031, Japan

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 require therapeutic upper gastrointestinal endoscopy (EMR or ESD) and meet the criteria (1)-(4) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study. The criteria (2) and (3) will be confirmed by the endoscopic observation just before starting the intended treatment.

  • Patients with an early gastric cancer located in the lower third of the stomach, who require therapeutic upper gastrointestinal endoscopy (EMR or ESD) (except for those with an intended treatment by using a scope of <9 mm in diameter)
  • Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in size, no ulcer finding
  • Patients with a single intended lesion for the treatment
  • 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 beforehand. The criteria (3) to (5) will be confirmed by the endoscopic observation just before starting the intended treatment.

  • Patients with a history of surgery to the upper gastrointestinal tract
  • Patients who require emergency endoscopy
  • Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
  • Patients who require emergency endoscopic treatment except for the intended lesion
  • Patients with a lesion extended to the pyloric ring
  • Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
  • Patients with pacemaker
  • Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
  • Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
  • Patients with contraindications to glucagon
  • Patients with contraindications to benzodiazepines, pethidine hydrochloride, and epinephrine
  • Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  • 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 opinion

Treatment and study plan

Menthol

Drug

20 mL NPO-11 in a prefilled plastic syringe

Placebo

Drug

The placebo is included same additives as active comparator.

Primary outcomes

  1. The proportion of patients had no or mild peristalsis during the therapeutic procedures

    Time frame: 60 minutes

    No or mild gastric peristalsis is defined as when patients have no or suppressed gastric peristalsis during the therapeutic procedure. The degree of gastric peristalsis in the time periods is assessed by an independent committee.

Secondary outcomes

  1. Duration of peristalsis-suppressing effect

    Time frame: 60 minutes

  2. Difficulty level of the therapeutic procedure

    Time frame: 60 minutes

  3. One-piece resection rate with tumor-free margin

    Time frame: 60 minutes

  4. Adverse events and adverse drug reactions

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Phase III Placebo-controlled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy (Randomized, Double-blind, Parallel-assignment, Placebo-controlled Study)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2011
Registry last updated
Jun 29, 2012

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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