Clinical Project Manager Braintree Laboratories, Inc. Braintree, MA
Matthew L. Walker, PhD1, Jack A. DiPalma, MD, MACG2, Raj Bhandari, MD3, Mark Cleveland, PhD4, Jessica Tesoriero1, Sue Hall, PhD5, John McGowan, MPH1; 1Braintree Laboratories, Inc., Braintree, MA; 2University of South Alabama, Mobile, AL; 3Delta Research Partners, Bastrop, LA; 4Mark Cleveland, Norwell, MA; 5Braintree Laboratories, Inc., Roswell, GA
Introduction: A new tablet bowel prep for colonoscopy has been developed containing poorly absorbed sulfate salts which pull water across the intestinal lumen resulting in copious diarrhea, thereby cleansing the bowel. This study evaluated the safety and efficacy of these oral sulfate tablets (OST) compared to an FDA-approved bowel prep containing PEG3350, electrolytes and ascorbate (PEG-EA). Methods: In this multi-center study, 515 adult patients (mean age 57 years) were randomly assigned to either OST or PEG-EA to be administered in a split-dose (PM/AM) regimen starting the evening prior to colonoscopy. PEG-EA was taken according to its approved label. OST patients consumed 12 tablets per dose with 16 oz of water, with another 32 oz of water with each dose. Patients then returned to the clinic for colonoscopy and answered the following questions: • How easy or difficult was it to consume the study preparation? • Please describe your overall experience with the bowel preparation? • How did this bowel preparation experience compare to your prior experiences? • Would you ask your doctor for this preparation again if you need another colonoscopy in the future? • Would you refuse the same preparation again if it were to be prescribed to you in the future?
Results: Nearly all patients in the study were able to complete both doses of their prep (OST – 98%, PEG-EA – 95%). More patients found it Easy or Very Easy to consume the OST prep compared to PEG-EA (65% vs 40%, respectively, p< 0.001). Overall experience ratings also favored OST, with 72% of OST patients rating the experience as Excellent or Good, compared to 60% for PEG-EA (p=0.004). Of the 319 patients who had a prior colonoscopy, more OST patients rated their experience as better than their prior prep (65% vs 46%, p< 0.001). More OST patients (78%) would request the prep again compared to PEG-EA (67%, p=0.005). The proportion of patients that would refuse this prep in the future was similar between groups (about 18%). Discussion: In a large multi-center study, the new oral sulfate tablet preparation was demonstrated to be highly preferred by patients over PEG-EA.
Disclosures: Matthew Walker: Braintree Laboratories Inc. – Employee. Jack DiPalma: Braintree Laboratories Inc. – Other Financial or Material Support, Consultant Medical Director. Raj Bhandari: Braintree Laboratories Inc. – Grant/Research Support. Mark Cleveland: Braintree Laboratories – Consultant. Braintree Laboratories Inc. – Consultant. Jessica Tesoriero: Braintree Laboratories Inc. – Employee. Sue Hall: Braintree Laboratories Inc. – Employee. John McGowan: Braintree Laboratories Inc. – Employee.