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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Menthol
Placebo
Sponsored by
Nihon Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring upper gastrointestinal endoscopy, suspected gastric cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

  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

Sites / Locations

  • Nihon Pharmaceutical Co., Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Menthol

Placebo

Arm Description

20 ml NPO-11

20 ml NPO-11(Placebo)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of peristalsis-suppressing effect
Difficulty level of the therapeutic procedure
One-piece resection rate with tumor-free margin
Adverse events and adverse drug reactions

Full Information

First Posted
August 2, 2011
Last Updated
June 27, 2012
Sponsor
Nihon Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01411176
Brief Title
Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nihon Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
upper gastrointestinal endoscopy, suspected gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menthol
Arm Type
Active Comparator
Arm Description
20 ml NPO-11
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 ml NPO-11(Placebo)
Intervention Type
Drug
Intervention Name(s)
Menthol
Intervention Description
20 mL NPO-11 in a prefilled plastic syringe
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo is included same additives as active comparator.
Primary Outcome Measure Information:
Title
The proportion of patients had no or mild peristalsis during the therapeutic procedures
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Duration of peristalsis-suppressing effect
Time Frame
60 minutes
Title
Difficulty level of the therapeutic procedure
Time Frame
60 minutes
Title
One-piece resection rate with tumor-free margin
Time Frame
60 minutes
Title
Adverse events and adverse drug reactions
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nihon Pharmaceutical Co., Ltd
City
Tokyo
ZIP/Postal Code
101-0031
Country
Japan

12. IPD Sharing Statement

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

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