A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy.

"CONFLICTS OF INTEREST Guarantor of article: Jack A. Di Palma, MD, MACG. Specific author contributions: J.A.D.P.—planning, conducting, monitoring, analysis, and writing of report, R.B. and D.S.M.—study participants, collecting data, and reviewing manuscript. M.vB.C., S.H., J.T., and J.M.—planning, collection of data, analysis, writing, and review of manuscript. Each author has approved the final draft. Financial support: Braintree Laboratories, part of Sebela Phamaceuticals, Inc. Potential competing interests: J.A.D.P. is a consultant medical director of Braintree Laboratories. M.vB.C. is a scientific consultant for Braintree Laboratories. S.H., J.T., and J.M. are employees of Braintree Laboratories, Inc.Study HighlightsWHAT IS KNOWN✓ Bowel preparation in essential for safe and effective diagnostic and therapeutic procedures.✓ Available methods do not strike the base balance of efficacy, safety, and tolerance.WHAT IS NEW HERE✓ A new oral sulfate tablet is safe, effective, and well-tolerated."

"Financial support: Braintree Laboratories, part of Sebela Phamaceuticals, Inc."

"This investigator-blinded, randomized, controlled, noninferiority study was sponsored and conducted by Braintree Laboratories, Inc., Braintree, MA. The study compared OST (Braintree Laboratories, Inc.) with PEG-EA (MoviPrep, Salix Pharmaceuticals, Morrisville, NC) in outpatients undergoing colonoscopy for routine indications. The trial was registered at Clinicaltrials.gov (identifier NCT03404401) and approved by respective facility Institutional Review Boards. Written informed consent was obtained for all participating study subjects. Enrollment began on January 11, 2018, and the last subject completed on July 10, 2018."