NCT01689792已完成4 期
A Multi-centre, Randomised, Investigator-blinded Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Norgine
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Polyp detection rate
研究概览
简要总结
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's written informed consent must be obtained prior to inclusion.
- •Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy.
- •Willing to undergo a colonoscopy for diagnostic or surveillance purposes
- •Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening 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.
排除标准
- •History of gastric emptying disorders.
- •History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.
- •History of phenylketonuria.
- •Known glucose-6-phosphate dehydrogenase deficiency.
- •Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.
- •History of colonic resection.
- •Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs).
- •Presence of congestive heart failure (NYHA III + IV).
- •Acute life-threatening cardiovascular disease.
- •Documented history of severe renal insufficiency (creatinine clearance <30 ml/min).
- •Other contraindication described in the summary of product characteristics (SmPC) of either preparation.
- •Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly.
- •Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months.
- •Females who are pregnant, nursing or planning a pregnancy.
- •Patients who, in the opinion of the investigator, may not be compliant with the study requirements.
- •Previous participation in this clinical study.
研究组 & 干预措施
CitraFleet
Active Comparator
Administration of CitraFleet
干预措施: CitraFleet (Drug)
MOVIPREP
Experimental
Administration of MOVIPREP
干预措施: MOVIPREP (Drug)
结局指标
主要结局
Polyp detection rate
时间窗: At colonoscopy
Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist
次要结局
- Adenoma Detection Rate (ADR)(At the Colonoscopy)
- ADR and PDR by location(at the colonoscopy)
- Cancer detection rate(at the colonoscopy)
- Flat lesion only detection rate(at the colonoscopy)
- Advanced risk lesion detection rate(at the colonoscopy)
- Colonoscopy completion rate(at the colonoscopy)
- Colon cleansing quality(at the colonoscopy)
- Acceptability and tolerability of medication using patient questionnaires(Throughout the study)
研究者
研究点 (1)
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