A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 13
- 主要终点
- The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NPF-08 （1-day treatment）
干预措施: NPF-08 （1-day treatment） (Drug)
NPF-08 （2-day split dose）
干预措施: NPF-08 （2-day split dose） (Drug)
Moviprep（1-day treatment）
干预措施: Moviprep（1-day treatment） (Drug)
结局指标
主要结局
The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).
时间窗: 1day
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. 1. Almost no residue is found in the intestinal tract enabling good observation 2. Residue remains but does not interfere the observation 3. Residue interferes the observation 4. A lot of residue makes unable to observe 5. Unable to evaluate
次要结局
- The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists(1day)
- Colon cleansing effect by site(1day)
- Evaluation based on Ottawa Bowel Preparation Scale(1day)
- Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.(1day)
- Dosage of the investigational product.(1day or 2day)
- Concordance rate of intestinal cleansing effect between by EIEC members.(1day)
- Concordance rate between the intestinal cleansing effect evaluated by EIEC and the endoscopic operators.(1day)
- Acceptability by subjects(1day)