A Phase III, Randomized, Assessor-Blinded, Parallel-Group, Multi-Centre, Clinical Study With FE 999169 for Oral Administration Versus Niflec® for Colon Cleansing: J-CLEAR
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 637
- 试验地点
- 1
- 主要终点
- The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale
研究概览
简要总结
To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.
详细描述
This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in Japanese patients. Patients, who signed an informed consent and fulfilled all screening criteria, were randomized in a 1:1:1 ratio to one of the following 3 treatment groups: "FE 999169 Split Dosing Schedule", "FE 999169 Day Before Dosing Schedule" and " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients, age 20 to 80 years inclusive, requiring colonoscopy
- •Female patients should be post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), or be surgically sterile, or be using medically approved contraception, throughout the trial period.
- •Fertile female patients must have a confirmed negative pregnancy test at screening and randomization
- •Patients must have had more than or equal to 3 spontaneous bowel movements per week prior to the colonoscopy
- •Written informed consent obtained prior to any study-related procedure
排除标准
- •Acute surgical abdominal conditions, such as acute intestinal obstruction or intestinal perforation, diverticulitis, appendicitis. If intestinal obstruction and perforation are suspected, perform appropriate diagnostic studies to rule out these conditions
- •Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
- •Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
- •Colon disease (history of colonic cancer, toxic megacolon, idiopathic pseudo-obstruction, hypomotility syndrome)
- •Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
- •Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
- •Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
- •Renal insufficiency (any of the serum creatinine, or serum potassium value exceeding the upper limits of the normal range at screening) or a history of this event
- •Participation in any other clinical trial during the past 3 months
- •Any clinically significant laboratory value at screening, including pre-existing electrolyte abnormality, based on clinical history that the investigators feel may affect the study evaluation
- •Hypersensitivity to active ingredients
- •Subject who cannot suspend the prohibited medications
- •Subjects not appropriate to participate in the study as deemed by the investigator
研究组 & 干预措施
Treatment arm [1]: FE 999169
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
干预措施: FE 999169 (Drug)
Treatment arm [2]: FE 999169
Two sachets on the day before colonoscopy
干预措施: FE 999169 (Drug)
Treatment arm [3]: Niflec
One to two pack(s) on the day of colonoscopy
干预措施: Niflec (Drug)
结局指标
主要结局
The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale
时间窗: Day 1 (day of colonoscopy)
The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.
次要结局
- Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire(Day 0 - Day 1)
- The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale(Day 1 (day of colonoscopy))
- The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale(Day 1 (day of colonoscopy))