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

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411176
• Other study ID #: NPO-11-02/C-02
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2011
• Last updated: June 27, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Menthol
20 mL NPO-11 in a prefilled plastic syringe
• Placebo
The placebo is included same additives as active comparator.

Locations

Country	Name	City	State
Japan	Nihon Pharmaceutical Co., Ltd	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Duration of peristalsis-suppressing effect		60 minutes	No
Secondary	Difficulty level of the therapeutic procedure		60 minutes	No
Secondary	One-piece resection rate with tumor-free margin		60 minutes	No
Secondary	Adverse events and adverse drug reactions		7 days	Yes