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


Phase 3
20 Years
N/A
Not Enrolling
Both
Gastric Cancer, Colon Nos Polypectomy Tubular Adenoma, Gastric Adenoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

60 minutes

Safety Issue:

No

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

NPO-11-02/S-02

NCT ID:

NCT01411189

Start Date:

September 2011

Completion Date:

June 2012

Related Keywords:

  • Gastric Cancer
  • Colon Nos Polypectomy Tubular Adenoma
  • Gastric Adenoma
  • therapeutic upper gastrointestinal endoscopy
  • percutaneous endoscopic gastrostomy
  • endoscopic mucosal resection
  • endoscopic submucosal dissection
  • PEG
  • EMR
  • ESD
  • endoscopic hemostasis
  • Adenoma
  • Stomach Neoplasms

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