NCT07465705招募中3 期
A Phase III, International, Multicenter, Randomized, Parallel-group, Endoscopist-blinded Non-inferiority Study of the Efficacy, Safety and Patient Acceptance of Mannitol Versus Plenvu® in Bowel Preparation for Elective Colonoscopy. CLEARWAY
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- NTC srl
- 入组人数
- 412
- 试验地点
- 18
- 主要终点
- Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score
研究概览
简要总结
This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability of subject to consent and provide signed written informed consent.
- •Age ≥ 18 years.
- •Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- •Subjects willing and able to complete the entire study and to comply with instructions.
排除标准
- •Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy).
- •Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed.
- •Severe renal failure: eGFR < 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
- •Severe heart failure: New York Heart Association (NYHA) Class III-IV.
- •Severe anaemia (Hb ≤ 8 g/dl).
- •Chronic liver disease Child-Pugh class B or C.
- •Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges).
- •Clinically significant alterations of baseline haemato-chemical parameters.
- •Recent (< 6 months) symptomatic acute ischemic heart disease.
- •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.
- •History of paralysis of the gut (ileus).
- •History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
- •History of phenylketonuria (due to presence of aspartame).
- •History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
- •History of toxic megacolon.
- •Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy.
- •Suspected bowel obstruction or perforation.
- •Indication for partial colonoscopy.
- •Subjects who received an investigational drug or therapy within 5 half-lives of the first visit.
- •Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
- •Underwater colonoscopy instead of standard gas insufflation.
研究组 & 干预措施
1L PEG-Asc
Active Comparator
Two liters of overall preparation, taken according to split-dose regimen the same day of colonoscopy
干预措施: 1L PEG-Asc (Drug)
Test arm
Experimental
One day single dose preparation same day of colonoscopy
干预措施: 100g of Mannitol (Drug)
结局指标
主要结局
Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score
时间窗: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 after standard washing and air or CO2 insufflation for luminal distension.
次要结局
- Adenoma detection rate(During colonoscopy (visit4), maximum 28 days after signing the informed consent form))
- Caecal intubation rate(During colonoscopy (visit4), maximum 28 days after signing the informed consent form))
- Proportion of subjects undergoing colonoscopy who have to repeat the procedure(During colonoscopy (visit4), maximum 28 days after signing the informed consent form))
- Proportion of subjects undergoing colonoscopy with presence of colonic bubbles(During colonoscopy (visit4), maximum 28 days after signing the informed consent form))
研究者
研究点 (18)
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