A Safety and Efficacy Study of DCL-101 Compared to GoLYTELY

Completed · Phase 2

Conditions studied: Bowel Preparation Before Colonoscopy

In brief

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.

Key facts

Study ID

NCT02910440

Run by

Dark Canyon Laboratories, LLC

People needed

46

Starts

2017-01-01

Expected to finish

2017-11-01

Last updated by the study team

2020-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Asheville Gastroenterology — Asheville, North Carolina, United States
• Cumberland Research Associates LLC — Fayetteville, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Trial Management Associates — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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