ColonaryConcepts developed a novel colonoscopy prep solution which is as effective and safe as two currently available colonoscopy prep formulations, according to results from a Phase 2 study. Researchers presented the results on Oct. 17 at the American College of Gastroenterology 2016 Annual Scientific Meeting in Las Vegas.
"The ECP approach allows patients to eat solid food bars and drink palatable low-volume beverages, a patient-friendly design that participants in the study clearly favored over conventional preps," said Corey A. Siegel, MD, a co-founder of ColonaryConcepts, and director of the Inflammatory Bowel Disease Center at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.
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Researchers tested six formulations of the novel colonoscopy prep and randomized the formulations against two FDA-approved active comparators. The primary outcome was the percentage of study subjects with an endoscopic visibility rating of excellent or good, based on the Aronchick scale. The study included 65 subjects.
Here are four insights:
1. Among the 32 subjects using the top three most effective formulations of colonoscopy prep, 90.6 percent had a rating of excellent or good.
2. Among the 15 subjects using ColonaryConcepts' lead formulation, 93.3 percent had a rating of excellent or good.
3. Of the 14 subjects using the comparator products, 85.7 percent had a rating of excellent or good.
4. Over 64 percent of patients using ColonaryConcepts' lead formulation reported being satisfied or extremely satisfied with the experience as compared to 33.3 percent of the patients using the FDA-approved comparator products who reported the same.
"Patients participating in the study were nearly four times more likely to recommend [the novel colonoscopy prep] to their friends and family as compared to the standard colonoscopy prep," said Dr. Siegel.
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