Dataset Information

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

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.

SUBMITTER: Bachwich DR

PROVIDER: S-EPMC7678801 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Bachwich Dale R DR Lewis James D JD Kowal Vera O VO Jacobson Brian C BC Calderwood Audrey H AH Kochman Michael L ML

Clinical and translational gastroenterology 20201201 12

<h4>Introduction</h4>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.<h4>Methods</h4>This was a multicenter, randomized, investigator-blinded ...[more]

PMID: 33512795

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Project description:AimTo compare same-day whole-dose vs split-dose of 2-litre polyethylene glycol electrolyte lavage solution (PEG-ELS) plus bisacodyl for colon cleansing for morning colonoscopy.MethodsConsecutive adult patients undergoing morning colonoscopy were allocated into two groups i.e., same-day whole-dose or split-dose of 2-litre PEG-ELS. Investigators and endoscopists were blinded to the allocation. All patients completed a questionnaire that was designed by Aronchick and colleagues to assess the tolerability of the bowel preparation regime used. In addition, patients answered an ordinal five-value Likert scale question on comfort level during bowel preparation. Endoscopists graded the quality of bowel preparation using the Boston bowel preparation scale (BBPS). In addition, endoscopists gave an overall grading of the quality of bowel preparation. Cecal intubation time, withdrawal time, total colonoscopy time, adenoma detection rate and number of adenomas detected for each patient were recorded. Sample size was calculated using an online calculator for binary outcome non-inferiority trial. Analyses was based upon intent-to-treat. Significance was assumed at P-value < 0.05.ResultsData for 295 patients were analysed. Mean age was 62.0 ± 14.4 years old and consisted of 50.2 % male. There were 143 and 152 patients in the split-dose and whole-dose group, respectively. Split-dose was as good as whole-dose for quality of bowel preparation. The total BBPS score was as good in the split-dose group compared to the whole-dose group [6 (6-8) vs 6 (6-7), P = 0.038]. There was no difference in cecal intubation rate, cecal intubation time, withdrawal time, total colonoscopy time and adenoma detection rate. Median number of adenoma detected was marginally higher in the split-dose group [2 (1-3) vs 1 (1-2), P = 0.010]. Patients in the whole-dose group had more nausea (37.5% vs 25.2%, P = 0.023) and vomiting (16.4% vs 8.4%, P = 0.037), and were less likely to complete the bowel preparation (94.1% vs 99.3%, P = 0.020). Patients in the split-dose group were less likely to refuse the same bowel preparation regime (6.3% vs 13.8%, P = 0.033) and less likely to want to try another bowel preparation regime (53.8% vs 78.9%, P < 0.001).ConclusionSplitting reduced-volume PEG-ELS for morning colonoscopy is as effective as taking the whole dose on the same morning but is better tolerated and preferred by patients.

Project description:IMPORTANCE:Hepatic encephalopathy (HE) is a common cause of hospitalization in patients with cirrhosis. Pharmacologic treatment for acute (overt) HE has remained the same for decades. OBJECTIVE:To compare polyethylene glycol 3350-electrolyte solution (PEG) and lactulose treatments in patients with cirrhosis admitted to the hospital for HE. We hypothesized that rapid catharsis of the gut using PEG may resolve HE more effectively than lactulose. DESIGN, SETTING, AND PARTICIPANTS:The HELP (Hepatic Encephalopathy: Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution) study is a randomized clinical trial in an academic tertiary hospital of 50 patients with cirrhosis (of 186 screened) admitted for HE. INTERVENTIONS:Participants were block randomized to receive treatment with PEG, 4-L dose (n?=?25), or standard-of-care lactulose (n?=?25) during hospitalization. MAIN OUTCOMES AND MEASURES:The primary end point was an improvement of 1 or more in HE grade at 24 hours, determined using the hepatic encephalopathy scoring algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma). Secondary outcomes included time to HE resolution and overall length of stay. RESULTS:A total of 25 patients were randomized to each treatment arm. Baseline clinical features at admission were similar in the groups. Thirteen of 25 patients in the standard therapy arm (52%) had an improvement of 1 or more in HESA score, thus meeting the primary outcome measure, compared with 21 of 23 evaluated patients receiving PEG (91%) (P?<?.01); 1 patient was discharged before final analysis and 1 refused participation. The mean (SD) HESA score at 24 hours for patients receiving standard therapy changed from 2.3 (0.9) to 1.6 (0.9) compared with a change from 2.3 (0.9) to 0.9 (1.0) for the PEG-treated groups (P?=?.002). The median time for HE resolution was 2 days for standard therapy and 1 day for PEG (P?=?.01). Adverse events were uncommon, and none was definitely study related. CONCLUSIONS AND RELEVANCE:PEG led to more rapid HE resolution than standard therapy, suggesting that PEG may be superior to standard lactulose therapy in patients with cirrhosis hospitalized for acute HE. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01283152.

Dataset Information

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

Introduction

Methods

Results

Discussion

Publications

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

Similar Datasets

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