A Randomised, Single-Centre, Parallel-Group, Pilot Study to Assess the Efficacy, Safety and Patient Acceptability of a New 2-Litre Bowel Preparation Agent (MOVIPREP®) Compared With a Standard Bowel Preparation Agent (PICOLAX®)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon.
研究概览
简要总结
This will be a randomised, single-centre, single-blind, parallel-group, pilot study in patients undergoing colonoscopy.
The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut cleansing prior to colonoscopy.
The secondary objectives are to evaluate the safety, tolerability and acceptability of MOVIPREP versus PICOLAX for gut cleansing prior to colonoscopy.
详细描述
Gut cleansing will be performed using a split dose of MOVIPREP®, 1-litre solution (1x sachet A and 1x sachet B) in the evening prior to the day of colonoscopy and 1-litre solution (1x sachet A and 1x sachet B) in the morning of the colonoscopy, or PICOLAX®, 150 mL solution (1 sachet) before 8am on day prior to the day of colonoscopy, and 150 mL solution (1 sachet) 6 to 8 hours later.
The primary efficacy measure will be the degree of gut cleansing, as assessed by the physician performing the colonoscopy. A 5-grade scale will be used to assess each of the predefined colon areas, resulting in a final grading (A to D) of the overall quality of the bowel preparation treatment. Grades A and B will be considered as success, and Grades C and D as failure.
The secondary efficacy measures will be:
- is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
- taste acceptability
- ease of taking, and ability to complete the bowel preparation treatment
- recommended diet compliance
- would the patient be prepared to repeat the bowel preparation treatment if necessary?
- well-being and effect on usual activities whilst taking the bowel preparation treatment
- overall impression of the bowel preparation treatment prior to colonoscopy
- symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy
Safety and tolerability will be assessed through the collection of adverse events, clinical laboratory tests, physical examination, weight and vital signs (blood pressure and pulse rate) data.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent obtained prior to inclusion
- •male or female, aged 18 to 80 years, inclusive, scheduled to undergo a complete colonoscopy
- •willing, able and competent to complete the entire procedure and to comply with study instructions
- •females of childbearing potential must employ an adequate method of contraception
- •if an adequate method of contraception is not being used, the patient will be post hysterectomy, post bilateral oophorectomy, post menopause or have any other condition which precludes pregnancy
- •females of childbearing potential must undergo a pregnancy test
排除标准
- •gastro-intestinal obstruction or perforation
- •toxic megacolon, toxic colitis
- •congestive heart failure (New York Heart Association [NYHA] III + IV)
- •acute life-threatening cardiovascular disease
- •acute surgical abdominal conditions
- •untreated or uncontrolled arterial hypertension
- •known clinically significant reduced renal function with creatinine > 170 µmol/L
- •known clinically significant reduced liver function
研究组 & 干预措施
1
MOVIPREP
干预措施: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate (Drug)
2
Picolax
干预措施: NA picosulfate magnesium citrate (Drug)
结局指标
主要结局
Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon.
时间窗: 8 days
次要结局
- is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?(within 3 months)
- taste acceptability(8 days)
- ease of taking, and ability to complete, the bowel preparation treatment(8 days)
- recommended diet compliance(8 days)
- would the patient be prepared to repeat the bowel preparation treatment if necessary?(8 days)
- well-being and effect on usual activities whilst taking the bowel preparation treatment(8 days)
- overall impression of the bowel preparation treatment prior to colonoscopy(8 days)
- symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy(8 days)