EUCTR2019-002856-18-DE进行中（未招募）1 期
Efficacy and Safety of mAnniTol in bowel preparation: assessment of adequacy and presence of Intestinal levelS of hydrogen and methane during elective colonoscopy aFter mAnnitol or standard split 2-liter polyethylene glycol solution plus asCorbaTe – a phase II/III, International, multicentre, randomized, parallel-group, endoscOpist-bliNded, dose-finding/non-inferiority study - SATISFACTION - SATISFACTIO
TC s.r.l.0 个研究点目标入组 846 人开始时间: 2020年3月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 846
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
- 性别
- All
入选标准
- •1. Ability of patient to consent and provide signed written informed consent
- •2. Age >= 18 years
- •3. Males and females scheduled for elective (screening, surveillance or diagnostic) colonoscopy to be prepared and performed according to the European Society of Gastrointestinal Endoscopy (ESGE) Guideline
- •4. Patients willing and able to complete the entire study and to comply with instructions.
- •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 423
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 423
排除标准
- •1. Pregnancy or breastfeeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and must practice one of the following methods of birth control throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; intrauterine device in combination with a condom; double barrier method (condom and occlusive cap with spermicidal foam/gel/film/cream/suppository).
- •2. Severe renal failure: glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 estimated by means of simplified MDRD equation.
- •3. Severe heart failure: NYHA Class III-IV.
- •4. Severe anaemia (Hb = 8 g/dl).
- •5. Severe acute and chronically active Inflammatory Bowel Disease; patients in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease and Partial Mayo Score = 2 for Ulcerative Colitis) are allowed.
- •6. Chronic liver disease Child-Pugh class B or C.
- •7. Electrolyte disturbances (Na, Cl, K, Ca or P out of normal ranges).
- •8. Recent (< 6 months) symptomatic acute ischemic heart disease.
- •9. History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann’s procedure and other surgeries involving the structure and function of the colon.
- •10. Use of laxatives, colon motility altering drugs and/or other substances (e.g. simethicone) that can affect bowel cleansing or visibility during colonoscopy within 24 hours prior to colonoscopy.
- •11. Suspected bowel obstruction or perforation.
- •12. Indication for partial colonoscopy.
- •13. Patients who have received an investigational drug or therapy within 5 half-lives of the first visit.
- •14. Patients previously screened for participation in this study.
- •15. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
- •16. Contraindication to Moviprep® (only for phase III).
研究者
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