Patients Who Receive Colonoscopy
Conditions
Interventions
investigational material(s)
Generic name etc : NPF-08
INN of investigational material : -
Therapeutic category code : 235 Purgatives and clysters
Dosage and Administration for Investigational material
Sponsors
Nihon Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The efficacy rate of overall intestinal cleansing effect | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Colon cleansing degree by site Evaluation based on Ottawa Bowel Preparation Scale Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy. | — |
Countries
Japan
Outcome results
None listed