Colon and rectal cancer
Patient-Friendly Colonoscopy Prep Is Safe and Effective
Detailed results from a Phase 2 study of a novel colonoscopy prep (ECP) under development by ColonaryConcepts, LLC show the investigational treatment to be at least as effective and safe as two currently available colonoscopy prep formulations, while offering a much higher level of patient satisfaction and preference than standard preps. The investigational prep is designed to be good-tasting, with no fasting and lower fluid requirements than standard preps. It consists of nutritionally balanced bars and beverages incorporating the standard purgative active ingredient, PEG 3350, which a patient consumes during the 24 hours prior to colonoscopy.
Results from the randomized, single-blind study were presented on October 17th at the American College of Gastroenterology 2016 Annual Scientific Meeting, in Las Vegas, NV, by principal investigator, Douglas K. Rex, M.D., Distinguished Professor of Medicine, Indiana University School of Medicine.
A release from Bioscribe Public Relations quotes Dr. Rex as saying, “Approximately 40% of those who ought to have a colonoscopy avoid the procedure, and the top reason cited for their avoidance is the prep. Results from this study show that this innovative investigational product performed as well as or better at colon cleansing than two currently available colonoscopy prep formulations. Moreover, the higher levels of patient satisfaction reported by those who used the lead ECP formulation in the trial suggest this new approach to colonoscopy prep may have a positive impact on patient willingness to undergo this potentially life-saving colorectal cancer screening procedure.”
The study tested six formulations of ECP, using different doses of the active ingredients integrated within different meal kit menus, randomized against two U.S. Food and Drug Administration-approved active comparators. The primary outcome was the proportion of subjects with an endoscopic visibility rating of excellent or good based on the Aronchick scale. Secondary endpoints included segment-by-segment endoscopic visibility based on the Ottawa scale, as well as safety, tolerability and reports of patient experience. Fifty-one patients were treated with ECP and 14 with active comparators.
In the top three most effective formulations of ECP, 90.6% (29 of 32) of patients had a rating of excellent or good. With ColonaryConcepts’ lead formulation, 93.3% (14 of 15) of patients had a rating of excellent or good, with 40 of 45 colon segments rated as excellent or good on the Ottawa scale. For the comparator products, 85.7% (12 of 14) had a rating of excellent or good. There were no serious adverse events across any of the treatment groups. The proportion of patients reporting being satisfied or extremely satisfied with the experience of using the lead ECP formulation was nearly double that for those using the standard preps, 64.3% versus 33.3%.