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To study non-inferiority of intestinal cleansing effect in both NPF-08 1-day treatment group and NPF-08 2-day split dose group to the cleansing effect in Moviprep® 1-day treatment group, for the subjects who will receive endoscopy large bowel. If the non-inferiority will be validated, superiority of intestinal cleansing effect in both groups of NPF-08 will be studied.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPF-08 (1-day treatment) | Experimental |
| |
| NPF-08 (2-day split dose) | Experimental |
| |
| Moviprep(1-day treatment) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPF-08 (1-day treatment) | Drug | NPF-08 will be administered on the day of colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC). | The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective.
| 1day |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists | The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisatsugu Asada | Nihon Pharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NPF-08 Trial Site 12 | Abiko | Chiba | Japan | |||
| NPF-08 Trial Site 11 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33476415 | Derived | 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. |
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| NPF-08 (2-day split dose) | Drug | NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy. |
|
| Moviprep(1-day treatment) | Drug | Moviprep will be administered on the day of colonoscopy. |
|
| 1day |
| Colon cleansing effect by site | The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated.
| 1day |
| Evaluation based on Ottawa Bowel Preparation Scale | Endoscopic operators will evaluate for colon cleansing degree at the bowel 5 sites (cecum/ascending colon, transverse colon, descending colon, sigmoid colon and rectum) based on the following 5 degrees (0-4) and the amount of fluid at overall bowel based on the following 3 degrees (0-2), and will also evaluate the status during operating normal endoscopy. Lower score indicates better cleansing effect. | 1day |
| Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy. | Clinical cooperator will determine the duration from the initiation of administration of the investigational product on the day of colonoscopy to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent. | 1day |
| Dosage of the investigational product. | Clinical cooperator will determine the dosage of the investigational product from the initiation of administration of the investigational product to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent. | 1day or 2day |
| Concordance rate of intestinal cleansing effect between by EIEC members. | For the evaluations of intestinal cleansing degree conducted at the primary endpoint, the concordance rate between by 3 members of EIEC will be investigated. | 1day |
| Concordance rate between the intestinal cleansing effect evaluated by EIEC and the endoscopic operators. | For the evaluations of intestinal cleansing degree conducted at the primary endpoint and secondary endpoints, the concordance rate between the evaluations by EIEC and that by the endoscopic operators will be investigated. | 1day |
| Acceptability by subjects | Subjects will evaluate the following points by selecting among 10 levels (circling the applicable figure): Taste of the investigational product; amount of the investigational product; amount of water you will drink after taking the investigational product; and acceptability of the pre-medication (will you choose the pre-medication at the next time?). | 1day |
| 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 |