HealthyPhase 3NCT00740324
Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men
A Phase 3 study testing NPO-11 in people with Healthy, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NPO-11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Aug 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 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.
- Volunteers who are in good health as confirmed by the investigator or subinvestigator
- Volunteers (age from 35 to less than 65 years old at the time of consent)
Who cannot join
- Volunteers who meet any of the following criteria will be excluded from the study.
- Volunteers with any clinically significant symptoms, physical findings or laboratory values at screening visit which are considered unsuitable for participation in the study in the investigator's or subinvestigator's opinion
- Volunteers with a history of surgery in the upper gastrointestinal tract
- Volunteers with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- Volunteers with a history of shock or hypersensitivity to scopolamine butylbromide, glucagon, lidocaine hydrochloride or heparin sodium
- Volunteers who are contraindicated for administration of scopolamine butylbromide or glucagon in the investigator's or subinvestigator's opinion based on health interview
Show all 9Show fewer
- Volunteers who have been exposed to NPO-11
- Volunteers who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- Volunteers otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men During Endoscopy
The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.
- Conditions
- Healthy
- Being tested
- NPO-11
- Keywords
- During, Endoscopy, Gastric, Peristalsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPO-11Drug
20 mg butylscopolammonium bromide after administration of NPO-11
NPO-11Drug
NPO-11 after administration of NPO-11
NPO-11Drug
1 mg glucagons after administration of NPO-11
| Study group | Role | What they receive |
|---|---|---|
| N | Active comparator | Not described Receives: Drug: NPO-11 |
| B | Active comparator | Not described Receives: Drug: NPO-11 |
| G | Active comparator | Not described Receives: Drug: NPO-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Measured: 7 ± 3 days after administration
Secondary outcomes (1)
[Efficacy] (Central evaluation by independent evaluator) (1) Change in the frequency of gastric peristalsis classification (2) Presence or absence of gastric peristalsis at each evaluation point
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 posted22 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740324
- Sponsor's protocol ID
- NPO-11-01/SE-02
- Status last verified
- Nov 2010
- First submitted
- 21 Aug 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
- Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men During Endoscopy
- ClinicalTrials.gov ID
- NCT00740324
- Acronym / sponsor ID
- NPO-11-01/SE-02
- Conditions
- Healthy
- Keywords
- During, Endoscopy, Gastric, Peristalsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 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.
The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N | Active comparator | Drug: NPO-11 |
| B | Active comparator | Drug: NPO-11 |
| G | Active comparator | Drug: NPO-11 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.
- Volunteers who are in good health as confirmed by the investigator or subinvestigator
- Volunteers (age from 35 to less than 65 years old at the time of consent)
Key exclusion criteria (9 listed)
- Volunteers who meet any of the following criteria will be excluded from the study.
- Volunteers with any clinically significant symptoms, physical findings or laboratory values at screening visit which are considered unsuitable for participation in the study in the investigator's or subinvestigator's opinion
- Volunteers with a history of surgery in the upper gastrointestinal tract
- Volunteers with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- Volunteers with a history of shock or hypersensitivity to scopolamine butylbromide, glucagon, lidocaine hydrochloride or heparin sodium
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 mg butylscopolammonium bromide after administration of NPO-11 | Drug | B |
| NPO-11NPO-11 after administration of NPO-11 | Drug | N |
| NPO-111 mg glucagons after administration of NPO-11 | Drug | G |
Primary outcome
[Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Time frame: 7 ± 3 days after administration
1 secondary outcome
[Efficacy] (Central evaluation by independent evaluator) (1) Change in the frequency of gastric peristalsis classification (2) Presence or absence of gastric peristalsis at each evaluation point
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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 NPO-11 in people with Healthy, 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 3 inclusion and 9 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 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. 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?
[Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration (time frame: 7 ± 3 days after administration). 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.