Patients Undergoing Gastric EndoscopyPhase 3NCT00742599
Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
A Phase 3 study testing NPO-11 in people with Patients Undergoing Gastric Endoscopy, run by Nihon Pharmaceutical Co., Ltd at 2 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Undergoing Gastric Endoscopy
- What is being tested?
- NPO-11
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2008to Jul 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 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
Who cannot join
- 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 Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-blind, Parallel-assignment , Placebo-controlled Study)
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.
- Conditions
- Patients Undergoing Gastric Endoscopy
- Being tested
- NPO-11, Placebo
- Keywords
- Stomach Diseases
- 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
PlaceboDrug
20 ml NPO-11(Placebo)
| Study group | Role | What they receive |
|---|---|---|
| N | Active comparator | Not described Receives: Drug: NPO-11 |
| P | Placebo comparator | Not described Receives: Drug: Placebo |
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 (3)
Change in gastric peristalsis
Measured: each evaluation point
Difficulty level of intragastric observation (evaluation by investigator who performs endoscopy)
Measured: each evaluation point
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 posted27 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Gastric EndoscopyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742599
- Sponsor's protocol ID
- NPO-11-01/C-01
- Status last verified
- Nov 2010
- First submitted
- 25 Aug 2008
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
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 Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-blind, Parallel-assignment , Placebo-controlled Study)
- ClinicalTrials.gov ID
- NCT00742599
- Acronym / sponsor ID
- NPO-11-01/C-01
- Conditions
- Patients Undergoing Gastric Endoscopy
- Keywords
- Stomach Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Aug 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N | Active comparator | Drug: NPO-11 |
| P | Placebo comparator | Drug: Placebo |
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 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
Key exclusion criteria (14 listed)
- 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)
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 |
| Placebo20 ml NPO-11(Placebo) | Drug | P |
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
3 secondary outcomes
Change in gastric peristalsis
Time frame: each evaluation point
Difficulty level of intragastric observation (evaluation by investigator who performs endoscopy)
Time frame: each evaluation point
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.
- Derived from this study: PubMed 21353674Hiki 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.
Related trials for Patients Undergoing Gastric Endoscopy
Active, not recruitingObservational study
Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy
GERD, Obesity
Enrolling by invitation
Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery
Obesity, Bariatric Surgery Candidate
Recruiting
Balloon Dilation in Patients Undergoing Minimally Invasive Ivor Lewis Esophagectomy and Its Effect on Reducing DGCE
Delayed Gastric Conduit Emtpying (DGCE), Minimally-invasive Esophagectomy
Enrolling by invitationObservational study
Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting
Gastric Outlet Obstruction Due to Malignancy, EUS Guided Enteroenteric Anastomosis
Recruiting
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
Hypoxia, Gastric Polyp
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.
2 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 Patients Undergoing Gastric Endoscopy, run by Nihon Pharmaceutical Co., Ltd at 2 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 14 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 2 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. 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?
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?
On the ClinicalTrials.gov record for NCT00742599, which also lists 1 linked publication.
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.