NCT00742599

Brief Summary

Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20 mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design 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 in comparison with the placebo group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

Enrollment Period

7 months

First QC Date

August 25, 2008

Last Update Submit

November 8, 2010

Conditions

Patients Undergoing Gastric Endoscopy

Keywords

Stomach Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in gastric peristalsis

    each evaluation point

  • Difficulty level of intragastric observation (evaluation by investigator who performs endoscopy)

    each evaluation point

  • Adverse events and ADRs observed between administration and 7±3 days after administration

    each evaluation point

Study Arms (2)

N

ACTIVE COMPARATOR
Drug: NPO-11

P

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NPO-11DRUG

20 ml NPO-11

N
PlaceboDRUG

20 ml NPO-11(Placebo)

P

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected upper gastrointestinal disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
  • Patients who need gastric endoscopy (except for endoscopy with a scope of \<9 mm in diameter, emergency endoscopy and endoscopy for comprehensive medical examination)
  • 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. The criteria (2) to (5) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.
  • Patients with a history of surgery to the upper gastrointestinal tract
  • Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
  • Patients with upper gastrointestinal bleeding which requires hemostasis
  • Patients with reflux esophagitis (Los Angeles classification: B, C or D)
  • Patients with gastric or duodenal ulcers in active stage
  • Patients on cancer treatment (chemotherapy or radiotherapy)
  • Patients with impaired cardiac function (NYHA functional classification: III or IV)
  • Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
  • Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
  • Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  • Patients who have been exposed to NPO-11
  • 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 or subinvestigator's opinion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Related Publications (1)

  • Hiki N, Kaminishi M, Yasuda K, Uedo N, Honjo H, Matsuhashi N, Hiratsuka T, Sekine C, Nomura S, Yahagi N, Tajiri H, Suzuki H. Antiperistaltic effect and safety of L-menthol sprayed on the gastric mucosa for upper GI endoscopy: a phase III, multicenter, randomized, double-blind, placebo-controlled study. Gastrointest Endosc. 2011 May;73(5):932-41. doi: 10.1016/j.gie.2010.12.013. Epub 2011 Feb 26.

    PMID: 21353674DERIVED

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 27, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

July 1, 2009

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations

JP(2)