NCT02910440已完成2 期
A Randomized, Investigator-blinded, Non-inferiority, Multicenter Study Evaluating the Safety and Efficacy of DCL-101 Compared to GoLYTELY in Adult Outpatients Undergoing Routine Colonoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Incidence of Graded Adverse Events
研究概览
简要总结
The primary objective of this Phase 2 Study was to compare the safety of 3 liter(L) and 4 liter(L) split dose DCL-101 to split dose 4L GoLYTELY in patients preparing for colonoscopy, with secondary objectives to assess tolerability and bowel cleansing efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating females, 18 to 75 years of age. Females of child bearing potential must have a negative urine pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
- •Routine, non-urgent, screening or surveillance colonoscopy is indicated and scheduled.
- •Ability of subject to participate fully in all aspects of this clinical trial, including ability and willingness to swallow capsules.
- •Informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained and documented from all subjects prior to the start of any study-specific procedures.
排除标准
- •Known hypersensitivity or allergy to any of the components of GoLYTELY or DCL-101
- •Actual or suspected ileus, gastrointestinal obstruction or other major structural gastrointestinal disorders, esophageal stricture, gastric retention, bowel perforation, toxic colitis, ischemic colitis, infectious colitis, toxic mega-colon, or inflammatory bowel disease. Diverticulitis within the past 6 weeks
- •Current or former tobacco users
- •Prior colorectal surgery, esophageal surgery, or gastric surgery. This includes colectomy in the past, colostomy, ulcer surgery (antrectomy or pyloroplasty) or bariatric surgery, including lap band or fundoplication
- •Chronic constipation, gastroparesis, esophageal motility disorders or other gut dysmotility disorders
- •Requiring medications that cannot have the administration schedule safely altered to be compatible with bowel preparation
- •Current or history within the past year of any ongoing clinically relevant electrocardiogram abnormalities
- •Clinically significant electrolyte abnormalities during Screening, defined by the range of normal of the central laboratory
- •Significant psychiatric illness
- •Renal failure or chronic kidney disease (creatinine clearance less than 50 mL/min, unstable angina, acute coronary syndrome/congestive heart failure (New York Heart Association Functional Classification grade III or IV), ascites
- •Received any investigational therapy within 60 days of randomization
- •Blood donation within 56 days prior to randomization
- •Plasma donation within 7 days prior to randomization
- •Received luminal contrast agents such as barium or water-soluble oral contrast agent within 21 days prior to randomization
- •Known to have an impaired gag reflex, or prone to regurgitation or aspiration
- •Serious underlying disease that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study
- •History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures
- •Pregnant or lactating women
- •Prior enrolment in the current study and had received study treatment
- •Cognitive barriers that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study
- •Inability to either read or understand English
研究组 & 干预措施
DCL-101
Experimental
干预措施: DCL-101 vs Golytely (Drug)
GoLytely
Active Comparator
干预措施: DCL-101 vs Golytely (Drug)
结局指标
主要结局
Incidence of Graded Adverse Events
时间窗: 2-6 hours after completion of investigational agent administration
Scale: Common Terminology Criteria for Adverse Events, a 5-point scale with Grade 1 equal to "mild" and Grade 5 equal to "death"
次要结局
- Incidence of abnormal urinalysis(7 days after completion of investigational agent administration)
- The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS)(At time of colonoscopy)
- The mean total score on the BBPS(At time of colonoscopy)
- Incidence of Serious Adverse Events(7 days after completion of investigational agent administration)
- Incidence of abnormal blood chemistries(7 days after completion of investigational agent administration)
- Incidence of Graded Adverse Events(7 days after completion of investigational agent administration)
- The proportion of subjects achieving an OBPQS score of 2 or less (excellent), with no segment score greater than 1, on the centrally read OBPQS(At time of colonoscopy)
- The proportion of subjects with segmental scores of 2 or greater on the BBPS for every one of the segments(At time of colonoscopy)
- Incidence of orthostatic hypotension(7 days after completion of investigational agent administration)
- Between group difference in the aggregate tolerability score (ATS) of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire(2-6 hours after completion of investigational agent administration)
- Between group difference in the Symptom Score of the Mayo Clinic Bowel Prep Tolerability Questionnaire(2-6 hours after completion of investigational agent administration)
- The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS)(At time of colonoscopy)
- The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS(At time of colonoscopy)
- Incidence of clinically significant electrocardiogram (ECG) changes(7 days after completion of investigational agent administration)
- Between group difference in score in individual aspects of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire(2-6 hours after completion of investigational agent administration)
- Proportion of subjects compliant with 100% of the study treatment regimen(At time of colonoscopy)
- Proportion of subjects compliant with 90% of the study treatment regimen(At time of colonoscopy)
- The Aronchick score (excellent, good, fair, poor, unsatisfactory)(At time of colonoscopy)
研究者
研究点 (5)
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