2025-521451-23-00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
Ntc S.r.l.19 个研究点 分布在 5 个国家目标入组 520 人开始时间: 2025年7月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 19
- 主要终点
- Proportion of patients 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.
研究概览
简要总结
To demonstrate the non-inferiority of mannitol vs. standard Plenvu® same-day dosing regimen in bowel cleansing for colonoscopy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Day after colonoscopy V5
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Ability of patient to consent and provide signed written informed consent.
- •Age ≥ 18 years.
- •Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- •Patients 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).
- •Recent (< 6 months) symptomatic acute ischemic heart disease.
- •History of paralysis of the gut (ileus).
- •History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
- •History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
- •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.
- •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.
- •Patients 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.
- •Severe acute and chronically active inflammatory bowel disease; patients 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.
- •Underwater colonoscopy instead of standard gas insufflation.
- •History of toxic megacolon.
- •History of phenylketonuria (due to presence of aspartame).
- •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.
结局指标
主要结局
Proportion of patients 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.
Proportion of patients 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, defined as the proportion of patients ≥ 45 years old without IBD undergoing colonoscopy who have at least one lesion detected.
- Caecal intubation rate, defined as the proportion of patients undergoing colonoscopy with ileocecal junction appendiceal orifice visible to the endoscopist.
- Proportion of patients undergoing colonoscopy who have to repeat the procedure due to inadequate intestinal cleansing to resolve, at the discretion of the endoscopist, the clinical issue underlying the request for colonoscopy.
- Proportion of patients undergoing colonoscopy with presence of colonic bubbles assessed through the Colon Endoscopic Bubble Scale (CEBuS).
- Number, appearance, size, location, and histological examination of neoplastic and inflammatory colorectal lesions.
- Adherence: study drug completely taken, partially taken, not taken.
- Ease of use: numeric rating scale (NRS) (0 = very difficult to 10 = very easy).
- Taste: NRS (0 = terrible to 10 = very good).
- Willingness to reuse the preparation (yes/no).
- Satisfaction with bowel preparation compared to cleansing agent used for previous colonoscopy
- Incidence of adverse events starting from the beginning of study drug administration.
- Incidence of drug-related adverse events starting from the beginning of study drug self-administration
- Proportion of patients with clinically significant change from baseline of haematological and chemical parameters 4 hours and 8 hours after completion of study drug self-administration, where clinically significant means that in the Investigator’s opinion the change needs an additional control or a medical intervention.
- Proportion of patients with clinically significant change from baseline of heart rate, systolic and diastolic blood pressure measured from the beginning of study drug self-administration to the end of study, as well as clinically significant change of oxygen saturation during colonoscopy, where clinically significant means that in the Investigator’s opinion the change needs an additional control or a medical intervention.
- PK sub-study: Maximum observed concentration (Cmax).
- PK sub-study: Time to maximum observed concentration (tmax).
- PK sub-study: Area under concentration-time curve, from 0 to the last blood sampling time point with measurable concentration (i.e., the last quantifiable timepoint) (AUC0-t0-t or AUClast).
- PK sub-study: Terminal elimination half-life (t1/2).
研究者
Dr. Alessandro Colombo
Scientific
Ntc S.r.l.
研究点 (19)
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