A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Degree of gut cleansing
研究概览
简要总结
A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use.
详细描述
A pilot monocentric, open phase I study to investigate the efficacy and safety of a new oral gut cleansing solution NRL994 in patients submitted to colonoscopy.
The study was carried out as an open, uncontrolled investigation in a group of 36 in-patients scheduled for colonoscopy. Patients were enrolled one or two days prior to the endoscopic procedure. Gut cleansing started in the evening prior to the intervention when the first dose of LDBP was taken; bowel preparation was continued in the morning of the day of colonoscopy when the second dose was taken. A patient's participation in the study ended after completion of the endoscopic procedure.
A dose of NRL994 was diluted in 1000 mL of water and consisted of 100 g PEG 3350, 7.5 g sodium sulphate, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, 46 mmol sodium chloride, and 12.46 mmol potassium chloride. The product was flavoured with lemon flavour (2.015 g), anhydrous citric acid (1.565 g), and potassium acesulfame (0.35 g).
Each dose of one litre had to be swallowed within one hour, followed by 500 mL of additional clear fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent must be obtained prior to inclusion
- •Male or female
- •Inpatients 18 to 60 years old with indication for complete colonoscopy
- •Willing and able 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
- •Intestinal obstruction or perforation.
- •Toxic megacolon.
- •History of any colonic surgery.
- •Cardiac Insufficiency (NYHA grad III and IV).
- •Ischemic cardio vascular disease.
- •Renal insufficiency (creatinine above 1.4 mg/100 ml).
- •Cirrhosis of liver (child B or C).
- •Known hypersensitivity to polyethylene glycols and/or Vitamin C.
- •Concurrent participation in an investigational drug study or participation within 30 days of study entry.
- •Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
- •Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
- •Abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit
- •Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmgH).
研究组 & 干预措施
NRL994 low dose bowel prep (LDBP)
Patients given two doses of NRL994, one on the evening before and one on the morning of their scheduled colonoscopy. Degree of gut cleansing was rated by the colonoscopist and an independent reviewer. Volume of fluid aspirated during colonoscopy and weight of stools/volume of urine from start of cleansing to start of colonoscopy were also measured. Number of patients who reached clear effluent evaluated.
干预措施: NRL994 (Drug)
结局指标
主要结局
Degree of gut cleansing
时间窗: Day 0 during colonoscopy
Degree of gut cleansing in each of five predefined gut segments (rectum, sigmoid colon, descending colon, transverse colon, ascending colon) rated on a 5-level verbal rating scale (VRS) ranging from 4 (very good) to 0 (very bad) by 1. the physician performing the endoscopic procedure and 2. by an independent reviewer on the basis of video tapes registered during colonoscopy.
Overall quality of colonic cleansing
时间窗: Day 0 during colonoscopy
Overall quality of colonic cleansing as rated on a 3-level VRS with ranks: A = very good or good colon cleansing in all five gut segments, B = at least one colon segment with moderate or bad cleansing result, C = very bad cleansing result in at least one colon segment.
Physicians overall judgement of colon preparation
时间窗: Day 0 during colonoscopy
Physicians overall judgement of colon preparation as assessed on a 5-level VRS ranging from very good to very bad.
Volume of fluid aspirated (ml)
时间窗: Day 0 during colonoscopy
Volume of fluid aspirated from intestinal lumen during colonoscopy.
Stool and urine weight (g)
时间窗: Day -1 and Day 0 prior to colonoscopy.
Weight of stools and urine sampled from the beginning of gut preparation until the start of the endoscopic procedure.
Clear effluent
时间窗: Day -1 and Day 0 prior to colonoscopy.
Number of patients in whom a clear effluent (containing no residual faecal material) was obtained.
Patient satisfaction - convenience
时间窗: Day -1 and Day 0 prior to colonoscopy
Patients overall judgement of convenience of use of LDBP as assessed in the CRF on a on a 5-level VRS ranging from 4 (very good) to 0 (very bad).
Patient satisfaction - taste
时间窗: Day -1 and Day 0 prior to colonoscopy
Patients overall judgement of the taste of LDBP as assessed in the CRF on a on a VAS ranging from 0 (very bad) to 100 mm (very good).
次要结局
- Adverse events(Day -1 and Day 0 prior to colonoscopy)
- Global tolerance(Day -1 and Day 0 prior to colonoscopy)
- Hematology(Day -2 to Day 0 prior to colonoscopy)
- Serum chemistry(Day -2 to Day 0 prior to colonoscopy)
- Urine electrolytes(Day -1 to Day 0 prior to colonoscopy)
- Blood pressure (mmHg)(Day -2 to Day 0 after colonoscopy)
- Pulse rate (bpm)(Day -2 to Day 0 after colonoscopy)
- Body weight (kg)(Day -1 prior to LDBP and Day 0 prior to colonoscopy.)