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

Primary Purpose

Gastric Cancer, Colon Nos Polypectomy Tubular Adenoma, Gastric Adenoma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Menthol
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 therapeutic upper gastrointestinal endoscopy, percutaneous endoscopic gastrostomy, endoscopic mucosal resection, endoscopic submucosal dissection, PEG, EMR, ESD, endoscopic hemostasis

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 and meet criteria (1), (4), (6) and one from (2), (3) or (5) in the study. Patients have to provide written informed consent for voluntary participation in the study. The criteria (2) to (4) will be confirmed by the endoscopic observation just before starting the intended treatment.

  1. Patients who require therapeutic upper gastrointestinal endoscopy (polypectomy, endoscopic hemostasis, PEG, EMR and ESD)
  2. Patients with a differentiated-type intramucosal gastric cancer located in the upper or middle third of the stomach (≤2 cm in size, no ulcer finding, EMR or ESD)
  3. Patients with a gastric adenoma (≤2 cm in size, no ulcer finding, EMR or ESD)
  4. Patients with an a single intended lesion for the treatment
  5. Patients without experience of PEG tube placement in case of PEG tube placement
  6. 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) and (4) 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 an ongoing cancer treatment (chemotherapy or radiotherapy)
  6. Patients with pacemaker
  7. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
  8. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
  9. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  10. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
  11. 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 Type

Other

Arm Label

Menthol

Arm Description

20 mL NPO-11

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 (for 45 s). 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
Adverse events and adverse drug reactions

Full Information

First Posted
August 3, 2011
Last Updated
June 27, 2012
Sponsor
Nihon Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01411189
Brief Title
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
Official Title
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
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 who require therapeutic upper gastrointestinal endoscopy, such as polypectomy, endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic therapeutic procedures will be evaluated 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colon Nos Polypectomy Tubular Adenoma, Gastric Adenoma
Keywords
therapeutic upper gastrointestinal endoscopy, percutaneous endoscopic gastrostomy, endoscopic mucosal resection, endoscopic submucosal dissection, PEG, EMR, ESD, endoscopic hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menthol
Arm Type
Other
Arm Description
20 mL NPO-11
Intervention Type
Drug
Intervention Name(s)
Menthol
Intervention Description
20 mL NPO-11 in prefilled syringe
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 (for 45 s). 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
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 and meet criteria (1), (4), (6) and one from (2), (3) or (5) in the study. Patients have to provide written informed consent for voluntary participation in the study. The criteria (2) to (4) will be confirmed by the endoscopic observation just before starting the intended treatment. Patients who require therapeutic upper gastrointestinal endoscopy (polypectomy, endoscopic hemostasis, PEG, EMR and ESD) Patients with a differentiated-type intramucosal gastric cancer located in the upper or middle third of the stomach (≤2 cm in size, no ulcer finding, EMR or ESD) Patients with a gastric adenoma (≤2 cm in size, no ulcer finding, EMR or ESD) Patients with an a single intended lesion for the treatment Patients without experience of PEG tube placement in case of PEG tube placement 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) and (4) 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 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 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 Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

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