A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based Colonoscopy Prep, Vs 4L Polyethylene Glycol-Electrolyte Solution

Overview

Journal Clin Transl Gastroenterol

Specialty Gastroenterology

Date 2021 Jan 29

PMID 33512795

Authors

Dale R Bachwich

James D Lewis

Vera O Kowal

Brian C Jacobson

Audrey H Calderwood

Michael L Kochman

Affiliations

Soon will be listed here.

Abstract

Introduction: DCL-101, a novel Pill Prep, is compositionally identical to standard 4L polyethylene glycol-electrolyte solution (PEG-ELS) and delivers the salt encapsulated, with PEG 3350 coadministered as a taste-free oral solution. The aim of this study was to compare the safety, taste, and tolerability of DCL-101 with 4L PEG-ELS in outpatients preparing for colonoscopy, with a secondary objective to assess efficacy.

Methods: This was a multicenter, randomized, investigator-blinded, phase 2 clinical trial of 45 adult patients undergoing outpatient colonoscopy. Patients were randomized 2:1 to either DCL-101 (3L in cohort 1; 4L in cohort 2) or 4L PEG-ELS, each administered with split dosing. Safety was assessed over 3 post-treatment clinic visits. Tolerability was measured using the Lawrance Bowel-Preparation Tolerability Questionnaire and the Mayo Clinic Bowel Prep Tolerability Questionnaire. Efficacy was determined by expert central readers, blinded to treatment, using the Ottawa Bowel Preparation Quality Scale, Boston Bowel Preparation Scale, and Aronchick scale.

Results: Both DCL-101 doses had superior taste and tolerability relative to 4L PEG-ELS. All adverse events were grade 1 with no significant differences in adverse events among the 3 regimens. There were no significant differences in efficacy among the 3 treatments as defined by the centrally read Ottawa Bowel Preparation Quality Scale, Boston Bowel Preparation Scale, or Aronchick scores. There were no inadequate preps as judged by the site endoscopist.

Discussion: DCL-101 Pill Prep is a novel strategy that vastly improves the taste and tolerability of PEG-ELS solutions with safety and efficacy comparable with split-dose 4L PEG-ELS solutions.

References

Rex D . Hyperosmotic low-volume bowel preparations: Is NER1006 safe?. Gastrointest Endosc. 2018; 89(3):656-658. DOI: 10.1016/j.gie.2018.11.009. View

MacPhail M, Hardacker K, Tiwari A, Vemulapalli K, Rex D . Intraprocedural cleansing work during colonoscopy and achievable rates of adequate preparation in an open-access endoscopy unit. Gastrointest Endosc. 2014; 81(3):525-30. DOI: 10.1016/j.gie.2014.05.002. View

Lai E, Calderwood A, Doros G, Fix O, Jacobson B . The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009; 69(3 Pt 2):620-5. PMC: 2763922. DOI: 10.1016/j.gie.2008.05.057. View

Harewood G, Wiersema M, Melton 3rd L . A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002; 97(12):3186-94. DOI: 10.1111/j.1572-0241.2002.07129.x. View

Rostom A, Jolicoeur E, Dube C, Gregoire S, Patel D, Saloojee N . A randomized prospective trial comparing different regimens of oral sodium phosphate and polyethylene glycol-based lavage solution in the preparation of patients for colonoscopy. Gastrointest Endosc. 2006; 64(4):544-52. DOI: 10.1016/j.gie.2005.09.030. View

Rex D . Bowel preparation for colonoscopy: entering an era of increased expectations for efficacy. Clin Gastroenterol Hepatol. 2013; 12(3):458-62. DOI: 10.1016/j.cgh.2013.11.003. View

Aronchick C, Lipshutz W, Wright S, Dufrayne F, Bergman G . A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000; 52(3):346-52. DOI: 10.1067/mge.2000.108480. View

Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R . Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019; 51(8):775-794. DOI: 10.1055/a-0959-0505. View

Zorzi M, Valiante F, Germana B, Baldassarre G, Coria B, Rinaldi M . Comparison between different colon cleansing products for screening colonoscopy. A noninferiority trial in population-based screening programs in Italy. Endoscopy. 2016; 48(3):223-31. DOI: 10.1055/s-0035-1569574. View

10.

Jones R, Woolf S, Cunningham T, Johnson R, Krist A, Rothemich S . The relative importance of patient-reported barriers to colorectal cancer screening. Am J Prev Med. 2010; 38(5):499-507. PMC: 2946819. DOI: 10.1016/j.amepre.2010.01.020. View

11.

Aoun E, Abdul-Baki H, Azar C, Mourad F, Barada K, Berro Z . A randomized single-blind trial of split-dose PEG-electrolyte solution without dietary restriction compared with whole dose PEG-electrolyte solution with dietary restriction for colonoscopy preparation. Gastrointest Endosc. 2005; 62(2):213-8. DOI: 10.1016/s0016-5107(05)00371-8. View

12.

Enestvedt B, Tofani C, Laine L, Tierney A, Fennerty M . 4-Liter split-dose polyethylene glycol is superior to other bowel preparations, based on systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2012; 10(11):1225-31. DOI: 10.1016/j.cgh.2012.08.029. View

13.

Patel M, Staggs E, Thomas C, Lukens F, Wallace M, Almansa C . Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014; 46(9):808-12. DOI: 10.1016/j.dld.2014.05.020. View

14.

Saltzman J, Cash B, Pasha S, Early D, Muthusamy V, Khashab M . Bowel preparation before colonoscopy. Gastrointest Endosc. 2015; 81(4):781-94. DOI: 10.1016/j.gie.2014.09.048. View

15.

Yang H, Park D, Park S, Lee C, Kim H, Oh S . Novel sulfate tablet PBK-1701TC versus oral sulfate solution for colon cleansing: A randomized phase 3 trial. J Gastroenterol Hepatol. 2019; 35(1):29-36. DOI: 10.1111/jgh.14826. View

16.

Kilgore T, Abdinoor A, Szary N, Schowengerdt S, Yust J, Choudhary A . Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2011; 73(6):1240-5. DOI: 10.1016/j.gie.2011.02.007. View

17.

DeMicco M, Clayton L, Pilot J, Epstein M . Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2017; 87(3):677-687.e3. DOI: 10.1016/j.gie.2017.07.047. View

18.

Lawrance I, Willert R, Murray K . A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci. 2012; 58(4):926-35. DOI: 10.1007/s10620-012-2449-0. View

19.

Rostom A, Jolicoeur E . Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004; 59(4):482-6. DOI: 10.1016/s0016-5107(03)02875-x. View

20.

Holt E, Yimam K, Ma H, Shaw R, Sundberg R, Verhille M . Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis. 2014; 23(2):135-40. DOI: 10.15403/jgld.2014.1121.232.ewh1. View