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

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ClinicalTrials.gov Identifier: NCT01411176
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol
U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. The proportion of patients had no or mild peristalsis during the therapeutic procedures [ Time Frame: 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 :
  1. Duration of peristalsis-suppressing effect [ Time Frame: 60 minutes ]
  2. Difficulty level of the therapeutic procedure [ Time Frame: 60 minutes ]
  3. One-piece resection rate with tumor-free margin [ Time Frame: 60 minutes ]
  4. Adverse events and adverse drug reactions [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411176


Locations
Japan
Nihon Pharmaceutical Co., Ltd
Tokyo, Japan, 101-0031
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01411176     History of Changes
Other Study ID Numbers: NPO-11-02/C-02
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012

Keywords provided by Nihon Pharmaceutical Co., Ltd:
upper gastrointestinal endoscopy
suspected gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Menthol
Antipruritics
Dermatologic Agents