Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2019-08-26
2020-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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NPO-13 0.8%
Low dose
NPO-13: l-menthol
20 mL/site
NPO-13 1.6%
High dose
NPO-13: l-menthol
20 mL/site
NPO-13 0%
Placebo
NPO-13: l-menthol
20 mL/site
Interventions
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NPO-13: l-menthol
20 mL/site
Eligibility Criteria
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Inclusion Criteria
2. Patients who need colonoscopy
Exclusion Criteria
2. Patients with contraindication to colonoscopy including the paralytic ileus
3. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
4. Patient with contraindication to bowel cleansing preparation
5. Patient with contraindication to pain medicine and sedative medicine
6. Patient with contraindication to butylscopolamine bromide and glucagon
7. Patients on cancer treatment (chemotherapy or radiotherapy)
8. Patient with active inflammatory bowel disease or infectious enteritis
9. Patients who need sedative in colonoscopy
10. Patients who receives a therapeutic colonoscopy
11. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
13. Patients otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion
20 Years
85 Years
ALL
No
Sponsors
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Nihon Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Hisatsugu Asada
Role: STUDY_CHAIR
Nihon Pharmaceutical Co., Ltd
Locations
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NPO-13 Trial Site 11
Kitakyushu, Fukuoka, Japan
NPO-13 Trial Site 12
Kurume, Fukuoka, Japan
NPO-13 Trial Site 2
Maebashi, Gunma, Japan
NPO-13 Trial Site 5
Yokohama, Kanagawa, Japan
NPO-13 Trial Site 6
Yokohama, Kanagawa, Japan
NPO-13 Trial Site 1
Shimotsuke, Tochigi, Japan
NPO-13 Trial Site 4
Minato, Tokyo, Japan
NPO-13 Trial Site 3
Shinjuku, Tokyo, Japan
NPO-13 Trial Site 9
Hiroshima, , Japan
NPO-13 Trial Site 13
Kagoshima, , Japan
NPO-13 Trial Site 10
Kochi, , Japan
NPO-13 Trial Site 7
Osaka, , Japan
NPO-13 Trial Site 8
Osaka, , Japan
Countries
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Other Identifiers
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NPO-13-01/ED-01
Identifier Type: -
Identifier Source: org_study_id
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