Bowel DiseasePhase 2NCT04097574
Study of NPO-13 During Colonoscopy
A Phase 2 study testing NPO-13: l-menthol in people with Bowel Disease, run by Nihon Pharmaceutical Co., Ltd at 13 sites in Japan.
Trial summary
This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed up to twice into ascending or sigmoid colon. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Bowel Disease
- What is being tested?
- NPO-13: l-menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 13 sitesJapan
- Study dates
- 26 Aug 2019to 26 Mar 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are between 20 and 85 years at the time of consent
- Patients who need colonoscopy
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
- Patient with contraindication to pain medicine and sedative medicine
- Patient with contraindication to butylscopolamine bromide and glucagon
Show all 13Show fewer
- Patients on cancer treatment (chemotherapy or radiotherapy)
- Patient with active inflammatory bowel disease or infectious enteritis
- Patients who need sedative in colonoscopy
- 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 otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
NPO-13 Trial Site 9
Hiroshima
NPO-13 Trial Site 13
Kagoshima
NPO-13 Trial Site 11
Kitakyushu, Fukuoka
NPO-13 Trial Site 10
Kochi
NPO-13 Trial Site 12
Kurume, Fukuoka
NPO-13 Trial Site 2
Maebashi, Gunma
NPO-13 Trial Site 4
Minato, Tokyo
NPO-13 Trial Site 7
Osaka
NPO-13 Trial Site 8
Osaka
NPO-13 Trial Site 1
Shimotsuke, Tochigi
NPO-13 Trial Site 3
Shinjuku, Tokyo
NPO-13 Trial Site 5
Yokohama, Kanagawa
NPO-13 Trial Site 6
Yokohama, Kanagawa
About this study
Official title: Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed up to twice into ascending or sigmoid colon. The colonic spasm will be assessed by an independent committee using recorded video images. The study consists of a screening visit window, 1-day treatment phase and 1-week follow-up phase.
- Conditions
- Bowel Disease
- Being tested
- NPO-13: l-menthol
- 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-13: l-mentholDrug
20 mL/site
| Study group | Role | What they receive |
|---|---|---|
| NPO-13 0.8% | Active comparator | Low dose Receives: Drug: NPO-13: l-menthol |
| NPO-13 1.6% | Active comparator | High dose Receives: Drug: NPO-13: l-menthol |
| NPO-13 0% | Placebo comparator | Placebo Receives: Drug: NPO-13: l-menthol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
Measured: 3 minutes
Secondary outcomes (5)
Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment
The secondary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
Measured: 3 minutes
Change in colonic spasm before and after treatment of NPO-13 treatment
The evaluated colonic spasm grades will be converted into a numeric score, and difference between paired mean scores (before and after application, or 0.8% NPO-13, 1.6% NPO-13 and placebo) will be calculated.
Measured: 3 minutes
Time to effect
The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm.
Measured: 3 minutes
Difficulty of endoscopic observation
The proportion of subjects in whom intracolonic examination will be evaluated by the investigator to be "Very easy" or "Easy"., using a four-grade scale: 1, Very easy; 2, Easy; 3, Difficult; 4, Hard.
Measured: 3 minutes
Adverse events and Adverse drug reactions
The subjects will be observed for 7 days after colonoscopy, and all adverse events and adverse drug reactions will be recorded and compared with the placebo group.
Measured: 7 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start26 Aug 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hisatsugu Asada, Study chair, Nihon Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097574
- Sponsor's protocol ID
- NPO-13-01/ED-01
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2019
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT04097574
- Acronym / sponsor ID
- NPO-13-01/ED-01
- Conditions
- Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 20 Sep 2019 (actual)
- 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.
This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed up to twice into ascending or sigmoid colon. The colonic spasm will be assessed by an independent committee using recorded video images. The study consists of a screening visit window, 1-day treatment phase and 1-week follow-up phase.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPO-13 0.8% | Active comparator | Drug: NPO-13: l-mentholLow dose |
| NPO-13 1.6% | Active comparator | Drug: NPO-13: l-mentholHigh dose |
| NPO-13 0% | Placebo comparator | Drug: NPO-13: l-mentholPlacebo |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are between 20 and 85 years at the time of consent
- Patients who need colonoscopy
Key exclusion criteria (13 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
- Patient with contraindication to pain medicine and sedative medicine
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: l-menthol20 mL/site | Drug | NPO-13 0%, NPO-13 0.8%, NPO-13 1.6% |
Primary outcome
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
Time frame: 3 minutes
The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
5 secondary outcomes
Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment
Time frame: 3 minutes
Change in colonic spasm before and after treatment of NPO-13 treatment
Time frame: 3 minutes
Time to effect
Time frame: 3 minutes
Difficulty of endoscopic observation
Time frame: 3 minutes
Adverse events and Adverse drug reactions
Time frame: 7 ± 3 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 17 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Hisatsugu Asada study chair
Nihon Pharmaceutical Co., Ltd
13 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: l-menthol in people with Bowel Disease, run by Nihon Pharmaceutical Co., Ltd at 13 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 2 inclusion and 13 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 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment (time frame: 3 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 17 Aug 2020; AzTrials last refreshed its copy on 2 Nov 2026.