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
PHASE3
632 participants
INTERVENTIONAL
2019-01-05
2019-06-19
Brief Summary
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Furthermore, for the assessment of safety of NPF-08, the adverse events and adverse drug reactions observed after the administration to post-examination period will be studied, compared to those at Moviprep® 1-day treatment group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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NPF-08 （1-day treatment）
NPF-08 （1-day treatment）
NPF-08 will be administered on the day of colonoscopy.
NPF-08 （2-day split dose）
NPF-08 （2-day split dose）
NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.
Moviprep（1-day treatment）
Moviprep（1-day treatment）
Moviprep will be administered on the day of colonoscopy.
Interventions
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NPF-08 （1-day treatment）
NPF-08 will be administered on the day of colonoscopy.
NPF-08 （2-day split dose）
NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.
Moviprep（1-day treatment）
Moviprep will be administered on the day of colonoscopy.
Eligibility Criteria
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Inclusion Criteria
2. Patients who require colonoscopy (except for emergency colonoscopy)
3. Patients who have the ability to consent and submit the written informed consent by themselves.
Exclusion Criteria
2. Patients who have or are suspected to have intestinal perforation.
3. Patients who have or are suspected to have toxic megacolon.
4. Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
5. Patients with intestinal stenosis or high-grade constipation (stool frequency of 2 or less in a week or who have used laxative on a daily basis).
6. Patients with vomiting reflex or in whom accidental ingestion may occur.
7. Patients with a history of gastrointestinal surgery (except for appendicectomy).
8. Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
9. Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
10. Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
11. Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
12. Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
13. Patients with dehydration.
14. Patients who were diagnosed with active inflammatory bowel disease at screening period.
15. Inpatients due to the reasons other than endoscopy large bowel.
16. Patients who have undergone nutritional control using total parenteral nutrition or enteral nutrition.
17. Women who are or may be pregnant, lactating or wish to become pregnant during the trial period.
18. Patients with a history or high-risk of seizure.
19. Patients with a history of shock or hypersensitivity for the active ingredient of the investigational product.
20. Patients who have received the other investigational product within 4 months before the written informed consent or who are participating in the other clinical trials.
21. Patients in whom Investigator/Sub-Investigator decided not to be eligible for this trial.
20 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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NPF-08 Trial Site 12
Abiko, Chiba, Japan
NPF-08 Trial Site 11
Kashiwa, Chiba, Japan
NPF-08 Trial Site 1
Maebashi, Gunnma, Japan
NPF-08 Trial Site 10
Kawasaki, Kanagawa, Japan
NPF-08 Trial Site 5
Yokohama, Kanagawa, Japan
NPF-08 Trial Site 9
Yokohama, Kanagawa, Japan
NPF-08 Trial Site 2
Chuo-Ku, Tokyo, Japan
NPF-08 Trial Site 3
Minato-Ku, Tokyo, Japan
NPF-08 Trial Site 4
Shinjuku-Ku, Tokyo, Japan
NPF-08 Trial Site 8
Hiroshima, , Japan
NPF-08 Trial Site 13
Kouchi, , Japan
NPF-08 Trial Site 6
Osaka, , Japan
NPF-08 Trial Site 7
Osaka, , Japan
Countries
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References
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Saito Y, Oka S, Tamai N, Kudo T, Kuniyoshi N, Shirakura T, Omae Y, Hamahata Y, Arai T, Tanaka S, Uedo N, Shimizu S, Fukuzawa M, Uraoka T, Ichinose S, Ogata H, Kobayashi K, Saito S, Tajiri H. Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study. Dig Endosc. 2021 Nov;33(7):1131-1138. doi: 10.1111/den.13930. Epub 2021 Mar 9.
Other Identifiers
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NPF-08-01/C-01
Identifier Type: -
Identifier Source: org_study_id
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