Clinical trial NCT03794310: Study of NPF-08 in Patients Who Receive Colonoscopy
Official title: A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients Who Receive Colonoscopy
Lead sponsor: Nihon Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 632
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Japanese men and women aged 20 years or older at obtaining the written informed consent.
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:

1. Patients who have or are suspected to have gastrointestinal obstruction.
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.

Primary outcomes:
measure: The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).
timeFrame: 1day
Secondary outcomes:
measure: The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists
timeFrame: 1day
measure: Colon cleansing effect by site
timeFrame: 1day
measure: Evaluation based on Ottawa Bowel Preparation Scale
timeFrame: 1day
measure: Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.
timeFrame: 1day
measure: Dosage of the investigational product.
timeFrame: 1day or 2day
measure: Concordance rate of intestinal cleansing effect between by EIEC members.
timeFrame: 1day
measure: Concordance rate between the intestinal cleansing effect evaluated by EIEC and the endoscopic operators.
timeFrame: 1day
measure: Acceptability by subjects
timeFrame: 1day
Other outcomes:
Locations:
city: Abiko
country: Japan
facility: NPF-08 Trial Site 12
state: Chiba
city: Kashiwa
country: Japan
facility: NPF-08 Trial Site 11
state: Chiba
city: Maebashi
country: Japan
facility: NPF-08 Trial Site 1
state: Gunnma
city: Kawasaki
country: Japan
facility: NPF-08 Trial Site 10
state: Kanagawa
city: Yokohama
country: Japan
facility: NPF-08 Trial Site 5
state: Kanagawa
city: Yokohama
country: Japan
facility: NPF-08 Trial Site 9
state: Kanagawa
city: Chuo-Ku
country: Japan
facility: NPF-08 Trial Site 2
state: Tokyo
city: Minato-Ku
country: Japan
facility: NPF-08 Trial Site 3
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: NPF-08 Trial Site 4
state: Tokyo
city: Hiroshima
country: Japan
facility: NPF-08 Trial Site 8
city: Kouchi
country: Japan
facility: NPF-08 Trial Site 13
city: Osaka
country: Japan
facility: NPF-08 Trial Site 6
city: Osaka
country: Japan
facility: NPF-08 Trial Site 7
Study officials:
affiliation: Nihon Pharmaceutical Co., Ltd
name: Hisatsugu Asada
role: STUDY_CHAIR
References:
citation: 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.