EUCTR2004-001487-43-GB进行中（未招募）1 期
A randomised, single-centre, single-blind,parallel group, pilot study to assess the efficacy, safety and patient acceptability of a new 2-litre bowel preparation agent (Moviprep) compared to a standard bowel preparation agent (Picolax) - Moviprep versus Picolax pilot study
orgine Ltd.0 个研究点目标入组 0 人开始时间: 2005年6月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
- •? severe uncontrolled inflammatory bowel disease
- •? known glucose-6-phosphatase dehydrogenase deficiency
- •? known phenylketonuria
- •? known hypersensitivity to polyethylene glycols, Vitamin C, sodium picosulphate or magnesium citrate
- •? concurrent participation in an investigational drug study or participation within 30 days of study entry
- •? administration of any other investigational or unapproved drug, or any other product known to cause gut cleansing (for example, Golytely, Golytely RSS, saline laxatives, strong laxatives, enemas) on Day 7 or 8 until after the colonoscopy.
- •? administration of ferrous supplements 1 week prior to their colonoscopy
- •? females who are pregnant, nursing or planning a pregnancy, or females of child-bearing potential not using reliable methods of contraception
- •? 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; this includes laboratory results.
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