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

NCT01411176 | Completed Phase 3

• 1 other identifier: NPO-11-02/C-02
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

upper gastrointestinal endoscopy; suspected gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  60 minutes

Secondary Outcomes (4)

• Duration of peristalsis-suppressing effect

  60 minutes

• Difficulty level of the therapeutic procedure

  60 minutes

• One-piece resection rate with tumor-free margin

  60 minutes

• Adverse events and adverse drug reactions

  7 days

Study Arms (2)

Menthol

ACTIVE COMPARATOR

20 ml NPO-11

Drug: Menthol

Placebo

PLACEBO COMPARATOR

20 ml NPO-11(Placebo)

Drug: Placebo

Interventions

Menthol DRUG

20 mL NPO-11 in a prefilled plastic syringe

Menthol

Placebo DRUG

The placebo is included same additives as active comparator.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nihon Pharmaceutical Co., Ltd: lead

Study Sites (1)

Nihon Pharmaceutical Co., Ltd

Tokyo, 101-0031, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Menthol

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 8, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 29, 2012

Record last verified: 2012-06

Locations

JP (1)