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.
Drug: DCL-101 vs Golytely
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Full eligibility criteria for NCT02910440
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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
All locations for NCT02910440
United States (5)
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Asheville, North Carolina, United States, 28801
Cumberland Research Associates LLC
Fayetteville, North Carolina, United States, 28304
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Trial Management Associates
Wilmington, North Carolina, United States, 28403
View full eligibility
Tris trial is registered with FDA with number: NCT02910440. The sponsor of the trial is Dark Canyon Laboratories, LLC and it is looking for 46 volunteers for the current phase.
Official trial title: 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
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