Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 12
- 主要终点
- Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").
研究概览
简要总结
To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies
详细描述
This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject's written informed consent had to be obtained prior to inclusion.
- •Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
- •Willing, able and competent to complete the entire procedure and to comply with study instructions
- •Females of childbearing potential had to employ an adequate method of contraception
排除标准
- •Intestinal obstruction or perforation
- •Toxic megacolon
- •History of colonic resection
- •Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
- •Congestive heart failure (NYHA III + IV)
- •Acute life threatening cardiovascular disease
- •Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg)
- •Known moderate to severe renal insufficiency
- •Severe renal failure
- •Severe liver failure
- •Known glucose 6 phosphatase dehydrogenase deficiency
- •Known phenylketonuria
- •Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
- •Concurrent participation in an investigational drug study or participation within 30 days of study entry
- •Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
- •Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.
研究组 & 干预措施
2
干预措施: Sodium Phosphate solution (NaP) (Drug)
1
2L gut cleansing solution
干预措施: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate (Drug)
结局指标
主要结局
Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").
次要结局
- the "overall" judgment of the investigator for the colon preparation was documented.
- Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
- The taste of the solutions was assessed.
- Acceptability and tolerance for the subject was compared.
- All Adverse Events were recorded to evaluate the safety.
- Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance.