CClinicalTrials.gg
Sign In
CompletedNCT00742599Updated Nov 9, 2010

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

A Phase 3 interventional study of NPO-11 and Placebo in Patients Undergoing Gastric Endoscopy, sponsored by Nihon Pharmaceutical Co., Ltd. Completed at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-11-09.

Sponsored by Nihon Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients Undergoing Gastric Endoscopy

Keywords

  • Stomach Diseases
03

In context

Lead sponsor

Nihon Pharmaceutical Co., Ltd is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

  1. Patients who need gastric endoscopy (except for endoscopy with a scope of \<9 mm in diameter, emergency endoscopy and endoscopy for comprehensive medical examination)
  2. Patients who are older than 20 years at the time of consent

Exclusion criteria

Exclusion Criteria:

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 Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.

  1. Patients with a history of surgery to the upper gastrointestinal tract
  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 with reflux esophagitis (Los Angeles classification: B, C or D)
  5. Patients with gastric or duodenal ulcers in active stage
  6. Patients on cancer treatment (chemotherapy or radiotherapy)
  7. Patients with impaired cardiac function (NYHA functional classification: III or IV)
  8. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
  9. Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
  10. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  11. Patients who have been exposed to NPO-11
  12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
  13. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    N

    Drug: NPO-11

  • Placebo comparator
    P

    Drug: Placebo

Interventions

  • DrugNPO-11

    20 ml NPO-11

  • DrugPlacebo

    20 ml NPO-11(Placebo)

06

What researchers measure

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.

    Time frame: each evaluation point

Secondary outcomes

  1. Change in gastric peristalsis

    Time frame: each evaluation point

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

    Time frame: each evaluation point

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

    Time frame: each evaluation point

07

Study locations

2 sites
  • Kansai, Japan
  • Kanto, Japan
08

References and documents

Publications

  • 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. PubMed 21353674 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00742599
Lead sponsor
Nihon Pharmaceutical Co., Ltd
First posted
Aug 27, 2008
Start date
Sep 2008
Primary completion
Apr 2009
Completion
Jul 2009
Last update
Nov 9, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Nihon Pharmaceutical Co., Ltd

Start the discussion