Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate
Michael P DeMicco, Lucy B Clayton, Jeff Pilot, Michael S Epstein, NOCT Study Group, Pradeep Kumar T Bekal, Michael DeMicco, Michael Epstein, Robert Hardi, Wayne L Harper, Joseph B Henderson, Vipul Jairath, Thomas E Jarrett, Kenneth L Kelln, Sayed S Khatami, Gina S Kwak, Barrett Levesque, Mahmoud Mosli, Walter Reinisch, Mariam S Sauer, Mark Silverberg, Kenneth E Smith, Michael P DeMicco, Lucy B Clayton, Jeff Pilot, Michael S Epstein, NOCT Study Group, Pradeep Kumar T Bekal, Michael DeMicco, Michael Epstein, Robert Hardi, Wayne L Harper, Joseph B Henderson, Vipul Jairath, Thomas E Jarrett, Kenneth L Kelln, Sayed S Khatami, Gina S Kwak, Barrett Levesque, Mahmoud Mosli, Walter Reinisch, Mariam S Sauer, Mark Silverberg, Kenneth E Smith
Abstract
Background and aims: NER1006 is the first 32 fluid ounce (1 L) polyethylene glycol-based bowel preparation. This randomized, multicenter, colonoscopist/central reader-blinded phase 3 non-inferiority trial assessed the efficacy, safety, and tolerability of NER1006 versus trisulfate for bowel cleansing.
Methods: Patients undergoing colonoscopy were randomized (1:1) to receive NER1006 or trisulfate, using evening/morning split-dosing administration. Blinded central readers used the validated Harefield Cleansing Scale to evaluate 2 alternative primary endpoints: overall bowel-cleansing success and high-quality cleansing of the ascending colon/cecum. Secondary endpoints included lesion detection, Boston Bowel Preparation Scale (BBPS) assessment, and adherence. The non-inferiority margin was 10% and the significance threshold was P < .025.
Results: Of 621 patients randomized (NER1006, n=310; trisulfate, n=311), 556 were evaluated for efficacy (NER1006, n=276; trisulfate, n=280). NER1006 achieved non-inferiority versus trisulfate for both primary endpoints of overall bowel-cleansing success (85.1% vs 85.0%; difference, 0.14%; one-sided 97.5% lower confidence limit [LCL], -8.15%; P = .528) and high-quality cleansing of the ascending colon/cecum (35.9% versus 29.3%; difference, 6.58%; LCL, -1.69%; P = .059). BBPS assessments supported overall bowel-cleansing success rates. Lesion detection rates were similar between the groups. The percentage of patients with treatment-related adverse events was 14.9% with NER1006 and 9.4% with trisulfate. Both bowel preparations showed similar overall tolerability and safety profiles. Adherence was very high in both arms.
Conclusions: With evening/morning split dosing, NER1006 was as effective as trisulfate for overall bowel and right-sided colon cleansing. Adverse event rates were slightly higher with NER1006 than trisulfate, but did not compromise tolerability, adherence, or efficacy. (Clinical trial registration number: NCT02254486.).
Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
Source: PubMed