Bowel DiseasePhase 2NCT02265939
Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy
A Phase 2 study testing NPO-13 in people with Bowel Disease, run by Nihon Pharmaceutical Co., Ltd at 3 sites in Japan.
Trial summary
Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy. The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bowel Disease
- What is being tested?
- NPO-13
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 3 sitesJapan
- Study dates
- Oct 2014to Mar 2015
- Phase
- Phase 2
- 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 colonic 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 colonoscopy
- Patients who are older than 20 years at the time of consent
Who cannot join
- Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation
- Patients with contraindication to colonoscopy including the paralytic ileus
- Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- Patient with contraindication to bowel cleansing preparation
- Patients on cancer treatment (chemotherapy or radiotherapy)
- Patients who need sedative colonoscopy
Show all 11Show fewer
- Patients who receives a therapeutic colonoscopy
- 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 who have been exposed to NPO-13
- Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Trial locations and contacts
3 sites in 1 country.
About this study
Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy.
The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be assessed by an independent committee using recorded video images.
The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.
- Conditions
- Bowel Disease
- Being tested
- NPO-13
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPO-13Drug
| Study group | Role | What they receive |
|---|---|---|
| 0% NPO-13 | Placebo comparator | Placebo Receives: Drug: NPO-13 |
| 0.2% NPO-13 | Active comparator | Low dose Receives: Drug: NPO-13 |
| 0.4% NPO-13 | Active comparator | Medium dose Receives: Drug: NPO-13 |
| 0.8% NPO-13 | Active comparator | High dose Receives: Drug: NPO-13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of the splayed region with no contraction after NPO-13 dosage
Measured: 3 min
Secondary outcomes (5)
The proportion of the splayed region with an onset of action
Measured: 3 min
The proportion of patients with no contraction in all the sprayed regions
Measured: 3 min
The proportion of patients with no contraction in one or more the sprayed region
Measured: 3 min
Change in colonic contraction
Measured: 3 min
Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DiseaseStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 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
- NCT02265939
- Sponsor's protocol ID
- NPO-13
- Status last verified
- Apr 2015
- First submitted
- 11 Oct 2014
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy
- ClinicalTrials.gov ID
- NCT02265939
- Acronym / sponsor ID
- NPO-13
- Conditions
- Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Oct 2014 (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 screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy.
The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be assessed by an independent committee using recorded video images.
The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0% NPO-13 | Placebo comparator | Drug: NPO-13Placebo |
| 0.2% NPO-13 | Active comparator | Drug: NPO-13Low dose |
| 0.4% NPO-13 | Active comparator | Drug: NPO-13Medium dose |
| 0.8% NPO-13 | Active comparator | Drug: NPO-13High dose |
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 colonic 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 colonoscopy
- Patients who are older than 20 years at the time of consent
Key exclusion criteria (11 listed)
- Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation
- Patients with contraindication to colonoscopy including the paralytic ileus
- Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- Patient with contraindication to bowel cleansing preparation
- 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-13 | Drug | 0% NPO-13, 0.2% NPO-13, 0.4% NPO-13, 0.8% NPO-13 |
Primary outcome
The proportion of the splayed region with no contraction after NPO-13 dosage
Time frame: 3 min
5 secondary outcomes
The proportion of the splayed region with an onset of action
Time frame: 3 min
The proportion of patients with no contraction in all the sprayed regions
Time frame: 3 min
The proportion of patients with no contraction in one or more the sprayed region
Time frame: 3 min
Change in colonic contraction
Time frame: 3 min
Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Time frame: up to 10 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 16 Nov 2021.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NPO-13 in people with Bowel Disease, run by Nihon Pharmaceutical Co., Ltd at 3 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 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the splayed region with no contraction after NPO-13 dosage (time frame: 3 min). 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 16 Nov 2021.