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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01411189
First received: August 3, 2011
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Colon Nos Polypectomy Tubular Adenoma
Gastric Adenoma
Drug: Menthol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

Resource links provided by NLM:


Further study details as provided by Nihon Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • The proportion of patients had no or mild peristalsis during the therapeutic procedures [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Difficulty level of the therapeutic procedure [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Adverse events and adverse drug reactions [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Menthol
20 mL NPO-11
Drug: Menthol
20 mL NPO-11 in prefilled syringe

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411189

Locations
Japan
Nihon Pharmaceutical Co., Ltd
Tokyo, Japan, 101-0031
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01411189     History of Changes
Other Study ID Numbers: NPO-11-02/S-02
Study First Received: August 3, 2011
Last Updated: June 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nihon Pharmaceutical Co., Ltd:
therapeutic upper gastrointestinal endoscopy
percutaneous endoscopic gastrostomy
endoscopic mucosal resection
endoscopic submucosal dissection
PEG
EMR
ESD
endoscopic hemostasis

Additional relevant MeSH terms:
Adenoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014