NCT00321230已完成2 期
A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
Norgine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2001年1月最近更新:
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相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.
研究概览
简要总结
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
详细描述
Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.
Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female, inpatients 18 to 65 years old with indication for complete colonoscopy
- •the patient's written informed consent must be obtained prior to inclusion
- •willing and able to complete the entire procedure and to comply with study instructions
排除标准
- •ileus or toxic megacolon
- •intestinal obstruction or perforation
- •known of G6PD insufficiency
- •history of any colonic surgery
- •ischaemic cardiovascular disease
- •untreated or uncontrolled arterial hypertension (max >170mmHg, min >100mmHg)
- •renal insufficiency (creating above 45µmol/l)
- •abnormal laboratory values (clinically significant) for sodium, potassium,chloride, creatinine and hematocrit
- •cirrhosis of liver (Child-Pugh grade B or C)
- •females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
- •concurrent participation in an investigational drug study or participation within 30 days of study entry
- •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
结局指标
主要结局
Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.
次要结局
- Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0).
- Amount of fluid removed from the colon during the colonoscopy.
研究者
研究点 (2)
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