Stomach DiseasesPhase 3NCT00745459
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
A Phase 3 study testing NPO-11 in people with Stomach Diseases, run by Nihon Pharmaceutical Co., Ltd at 4 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stomach Diseases
- What is being tested?
- NPO-11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesJapan
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients who require gastric endoscopy (except for emergency endoscopy or endoscopy for comprehensive medical examination)
- Patients who are older than 20 years at the time of consent
Who cannot join
- 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 Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.
- Patients with a history of surgery to the stomach
- Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- Patients with upper gastrointestinal bleeding which requires hemostasis
- Patients on cancer treatment (chemotherapy or radiotherapy)
- Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Chūbu
Study site
Kansai
Study site
Kanto
Study site
Shikoku
About this study
Official title: Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)
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.
Read more
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
- Conditions
- Stomach Diseases
- Being tested
- NPO-11
- Keywords
- Patients, undergoing, gastric, endoscopy
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPO-11Drug
20 mL NPO-11
| Study group | Role | What they receive |
|---|---|---|
| N | Experimental | 20 mL NPO-11 Receives: Drug: NPO-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: each evaluation point
Secondary outcomes (1)
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
Measured: each evaluation point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745459
- Sponsor's protocol ID
- NPO-11-01/S-01
- Status last verified
- Nov 2010
- First submitted
- 1 Sep 2008
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)
- ClinicalTrials.gov ID
- NCT00745459
- Acronym / sponsor ID
- NPO-11-01/S-01
- Conditions
- Stomach Diseases
- Keywords
- Patients, undergoing, gastric, endoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N | Experimental | Drug: NPO-1120 mL NPO-11 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Patients who require gastric endoscopy (except for emergency endoscopy or endoscopy for comprehensive medical examination)
- Patients who are older than 20 years at the time of consent
Key exclusion criteria (11 listed)
- 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.
- Patients with a history of surgery to the stomach
- Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- Patients with upper gastrointestinal bleeding which requires hemostasis
- Patients on cancer treatment (chemotherapy or radiotherapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPO-1120 mL NPO-11 | Drug | N |
Primary outcome
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
1 secondary outcome
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
Time frame: each evaluation point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPO-11 in people with Stomach Diseases, run by Nihon Pharmaceutical Co., Ltd at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.