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

Sponsor

Nihon Pharmaceutical Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01411176

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Menthol Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The proportion of patients had no or mild peristalsis during the therapeutic procedures [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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nihon Pharmaceutical Co., Ltd	Tokyo		Japan	101-0031

Sponsors and Collaborators

Nihon Pharmaceutical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nihon Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT01411176

Other Study ID Numbers:

NPO-11-02/C-02

First Posted:

Aug 8, 2011

Last Update Posted:

Jun 29, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Nihon Pharmaceutical Co., Ltd

upper gastrointestinal endoscopy

suspected gastric cancer

Additional relevant MeSH terms:

Stomach Neoplasms

Menthol

Study Results

No Results Posted as of Jun 29, 2012