Gastric CancerPhase 3NCT01411176
Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
A Phase 3 study testing Menthol in people with Gastric Cancer, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Menthol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2011to Jun 2012
- 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 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.
- 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)
- Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in size, no ulcer finding
- Patients with a single intended lesion for the treatment
- 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 beforehand. The criteria (3) to (5) will be confirmed by the endoscopic observation just before starting the intended treatment.
- Patients with a history of surgery to the upper gastrointestinal tract
- Patients who require emergency endoscopy
- Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- Patients who require emergency endoscopic treatment except for the intended lesion
- Patients with a lesion extended to the pyloric ring
Show all 15Show fewer
- Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
- Patients with pacemaker
- Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
- Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
- Patients with contraindications to glucagon
- Patients with contraindications to benzodiazepines, pethidine hydrochloride, and epinephrine
- Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
- 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 opinion
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Gastric Cancer
- Being tested
- Menthol, Placebo
- Keywords
- upper gastrointestinal endoscopy, suspected gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentholDrug
20 mL NPO-11 in a prefilled plastic syringe
PlaceboDrug
The placebo is included same additives as active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Menthol | Active comparator | 20 ml NPO-11 Receives: Drug: Menthol |
| Placebo | Placebo comparator | 20 ml NPO-11(Placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Secondary outcomes (4)
Duration of peristalsis-suppressing effect
Measured: 60 minutes
Difficulty level of the therapeutic procedure
Measured: 60 minutes
One-piece resection rate with tumor-free margin
Measured: 60 minutes
Adverse events and adverse drug reactions
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411176
- Sponsor's protocol ID
- NPO-11-02/C-02
- Status last verified
- Jun 2012
- First submitted
- 2 Aug 2011
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01411176
- Acronym / sponsor ID
- NPO-11-02/C-02
- Conditions
- Gastric Cancer
- Keywords
- upper gastrointestinal endoscopy, suspected gastric cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Aug 2011 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menthol | Active comparator | Drug: Menthol20 ml NPO-11 |
| Placebo | Placebo comparator | Drug: Placebo20 ml NPO-11(Placebo) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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)
- Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in size, no ulcer finding
- Patients with a single intended lesion for the treatment
- Patients who are older than 20 years at the time of consent
Key exclusion criteria (15 listed)
- 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.
- Patients with a history of surgery to the upper gastrointestinal tract
- Patients who require emergency endoscopy
- Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- Patients who require emergency endoscopic treatment except for the intended lesion
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 |
|---|---|---|
| Menthol20 mL NPO-11 in a prefilled plastic syringe | Drug | Menthol |
| PlaceboThe placebo is included same additives as active comparator. | Drug | Placebo |
Primary outcome
The proportion of patients had no or mild peristalsis during the therapeutic procedures
Time frame: 60 minutes
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.
4 secondary outcomes
Duration of peristalsis-suppressing effect
Time frame: 60 minutes
Difficulty level of the therapeutic procedure
Time frame: 60 minutes
One-piece resection rate with tumor-free margin
Time frame: 60 minutes
Adverse events and adverse drug reactions
Time frame: 7 days
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 29 Jun 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Menthol in people with Gastric Cancer, run by Nihon Pharmaceutical Co., Ltd at 1 site 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 5 inclusion and 15 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 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The proportion of patients had no or mild peristalsis during the therapeutic procedures (time frame: 60 minutes). 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 29 Jun 2012.