A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 3
- 主要终点
- Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
研究概览
简要总结
This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy
- •Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to the colonoscopy
排除标准
- •Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
- •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, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
- •Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
- •Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
- •Severely reduced renal function (Glomerular filtration rate (GFR) <30 (mL/min/1.73 m2))
- •The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:
- •Transdermal patch
- •Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
- •Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
- •Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
- •Sexual abstinence
- •The subject is a breast-feeding or lactating woman
研究组 & 干预措施
PICOPREP day-before dosing schedule
Both doses administered the day before colonoscopy.
干预措施: PICOPREP (Drug)
PICOPREP tailored dosing schedule
First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.
干预措施: PICOPREP (Drug)
结局指标
主要结局
Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
时间窗: Day 1 (day of colonoscopy)
Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
时间窗: Day 1 (day of colonoscopy)
Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
次要结局
- Ascending Colon Cleansing Responder Status (ITT)(Day 1 (day of colonoscopy))
- Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)(From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit))
- Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)(From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit))
- Frequency and Intensity of Adverse Events(From baseline (screening) up to day 10 after colonoscopy)