NCT02321462已完成3 期
Efficacy, Safety and Tolerability of a Split-dose of a New Bowel Cleansing Preparation (Eziclen) in Adult Subjects Undergoing Colonoscopy: A Phase III, Multicentre, Randomised, 2 Parallel Group, Comparative Versus Fortrans®, Non-inferiority, Investigator-blinded Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 296
- 试验地点
- 3
- 主要终点
- Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).
研究概览
简要总结
The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication.
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 (Investigator)
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
- •Provision of written informed consent signed prior to any study related procedures
- •Male or female, at least 18 years old undergoing colonoscopy for a routine diagnostic indication:
- •Routine cancer screening
- •Polyp or neoplasm history
- •Diagnostic procedure for occult bleeding or anaemia
- •Diarrhoea or constipation of unknown aetiology
- •IBD if not in severe acute phase
- •Abnormal ultrasound exam (i.e. mass in abdomen)
- •Evaluation of barium enema or computed tomography (CT) scan results
- •In good clinical condition (physical exam and medical history)
- •Subjects with an adequate fluid balance, and adequate electrolyte balance (measured during screening K, Na, Cl, bicarbonate within normal/near normal range)
排除标准
- •Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- •Has an advanced carcinoma or any other colon disease leading to excessive mucosal fragility.
- •Has a known or suspected gastrointestinal (GI) obstruction, gastric retention, gastroparesis, or disorder of gastric emptying.
- •Has a known or suspected ileus.
- •Has a bowel perforation.
- •Has profuse vomiting.
- •Needs a therapeutic procedure (e.g. polypectomy, mucosectomy).
- •Has toxic colitis or megacolon.
- •Is in severe acute phases of active IBD, as a contraindication for colonoscopy.
- •Has acute GI bleeding.
- •Underwent previous GI surgeries (e.g. colostomy, colectomy, gastric bypass, stomach stapling).
- •Has impaired consciousness predisposing to pulmonary aspiration.
- •Needs a colonoscopy for foreign body removal and decompression.
- •Underwent previous incomplete colonoscopy.
- •Has a known severe renal insufficiency (glomerular filtration rate (GFR) <30 mL/min/1.73 m2).
- •Has a known severe liver insufficiency (Child-Pugh grade C: 10 to 15 points).
- •Suffers from uncorrected dehydration.
- •Has ascites.
- •Suffers from severe congestive heart failure (classes III and IV).
- •Has hyperuricemia with clinical manifestation as gouty arthritis.
- •Is pregnant or lactating.
- •Is a female at risk of pregnancy and not using an acceptable contraceptive method during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), or injectable contraception or an intra-uterine device. Nonchildbearing potential is defined as postmenopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study.
- •Has any known hypersensitivity to the active substances or to any of the preparation excipients (Eziclen or Fortrans®: polyethylene glycol (PEG) (macrogol), sodium sulphate, potassium sulphate, magnesium sulphate, sodium chloride, potassium chloride, sodium bicarbonate, sucralose, sodium saccharin, sodium benzoate, citric acid, malic acid, and fruit cocktail flavor).
- •Patient has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
- •Patient was treated with any other IMP within the last 30 days before study entry
- •Patient is likely to require treatment during the study with drugs that are not permitted by the study protocol
研究组 & 干预措施
Eziclen
Experimental
干预措施: Eziclen (Drug)
Fortrans®
Active Comparator
干预措施: Fortrans® (Drug)
结局指标
主要结局
Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).
时间窗: Colonoscopy was performed on Day 2.
The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid, 2=-minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well, 3=entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid. A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments. The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (\<= 65; \> 65), gender and inflammatory bowel disease (IBD) status.
次要结局
- Mean BBPS Score by Segment and Globally (ITT Population)(Colonoscopy was performed on Day 2.)
- Mean Colonoscopy Duration(Colonoscopy was performed on Day 2.)
- Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)(Colonoscopy was performed on Day 2.)
- The Percentage of Patients in Whom Lesions Were Detected.(Colonoscopy was performed on Day 2.)
- The Percentage of Patients for Whom the Colonoscopy Was Completed(Colonoscopy was performed on Day 2.)
- Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation(Colonoscopy was performed on Day 2.)
- Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment(Study treatment was administered as a split-dose on Days 1 and 2.)
研究者
研究点 (3)
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