Status:
COMPLETED
Study of NPF-08 in Patients Who Receive Colonoscopy
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Patients Who Receive Colonoscopy
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 subje...
Eligibility Criteria
Inclusion
- Japanese men and women aged 20 years or older at obtaining the written informed consent.
- Patients who require colonoscopy (except for emergency colonoscopy)
- Patients who have the ability to consent and submit the written informed consent by themselves.
Exclusion
- Patients who have or are suspected to have gastrointestinal obstruction.
- Patients who have or are suspected to have intestinal perforation.
- Patients who have or are suspected to have toxic megacolon.
- Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
- 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).
- Patients with vomiting reflex or in whom accidental ingestion may occur.
- Patients with a history of gastrointestinal surgery (except for appendicectomy).
- Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
- Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
- Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
- Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
- Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
- Patients with dehydration.
- Patients who were diagnosed with active inflammatory bowel disease at screening period.
- Inpatients due to the reasons other than endoscopy large bowel.
- Patients who have undergone nutritional control using total parenteral nutrition or enteral nutrition.
- Women who are or may be pregnant, lactating or wish to become pregnant during the trial period.
- Patients with a history or high-risk of seizure.
- Patients with a history of shock or hypersensitivity for the active ingredient of the investigational product.
- 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.
- Patients in whom Investigator/Sub-Investigator decided not to be eligible for this trial.
Key Trial Info
Start Date :
January 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2019
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT03794310
Start Date
January 5 2019
End Date
June 19 2019
Last Update
November 29 2022
Active Locations (13)
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1
NPF-08 Trial Site 12
Abiko, Chiba, Japan
2
NPF-08 Trial Site 11
Kashiwa, Chiba, Japan
3
NPF-08 Trial Site 1
Maebashi, Gunnma, Japan
4
NPF-08 Trial Site 10
Kawasaki, Kanagawa, Japan