Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy

Stomach Diseases Clinical Trial

Official title:

Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745459
• Other study ID #: NPO-11-01/S-01
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2008
• Last updated: November 8, 2010
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2010
• 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 who require gastric endoscopy, including the patient population* excluded from the phase III controlled clinical study of NPO-11, will receive an intragastric single dose of NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure).

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.

Patient population excluded from the phase III controlled clinical study of NPO-11

• Patients with reflux esophagitis

• Patients with active gastric or duodenal ulcers

• Patients who undergo endoscopy under sedation

• Patients who undergo endoscopy with a scope of <9 mm in diameter

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

Inpatients or outpatients of either sex who meet criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.

1. Patients who require gastric endoscopy (except for emergency endoscopy or endoscopy for comprehensive medical examination)

2. 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. The criteria (2) and (3) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.

1. Patients with a history of surgery to the stomach

2. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult

3. Patients with upper gastrointestinal bleeding which requires hemostasis

4. Patients on cancer treatment (chemotherapy or radiotherapy)

5. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)

6. Patients with a history of shock or hypersensitivity to lidocaine hydrochloride

7. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study

8. Patients who have been exposed to NPO-11

9. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies

10. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion

Study Design

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

Related Conditions & MeSH terms

• Stomach Diseases

Intervention

Drug:
• NPO-11
20 mL NPO-11

Locations

Country	Name	City	State
n/a

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	Presence or absence of gastric peristalsis (central evaluation by independent evaluator) No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.		each evaluation point	No
Secondary	Change in gastric peristalsis (central evaluation by independent evaluator) Difficulty level of intragastric observation (evaluation by investigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration		each evaluation point	Yes