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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Menthol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 101-0031
    • Nihon Pharmaceutical Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

1. 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)
2. Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in size, no ulcer finding
3. Patients with a single intended lesion for the treatment
4. 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.

1. Patients with a history of surgery to the upper gastrointestinal tract
2. Patients who require emergency endoscopy
3. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
4. Patients who require emergency endoscopic treatment except for the intended lesion
5. Patients with a lesion extended to the pyloric ring
6. Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
7. Patients with pacemaker
8. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
9. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
10. Patients with contraindications to glucagon
11. Patients with contraindications to benzodiazepines, pethidine hydrochloride, and epinephrine
12. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
13. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
14. Patients otherwise ineligible for participation in the study in the investigator's opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Menthol; 20 ml NPO-11	Drug: Menthol; 20 mL NPO-11 in a prefilled plastic syringe
Placebo Comparator: Placebo; 20 ml NPO-11(Placebo)	Drug: Placebo; The placebo is included same additives as active comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients had no or mild peristalsis during the therapeutic procedures	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.	60 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of peristalsis-suppressing effect	60 minutes
Difficulty level of the therapeutic procedure	60 minutes
One-piece resection rate with tumor-free margin	60 minutes
Adverse events and adverse drug reactions	7 days

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: upper gastrointestinal endoscopy; suspected gastric cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: NPO-11-02/C-02