Dark Canyon Laboratories, LLC, Rapid City, South Dakota, USA.
Department of Internal Medicine and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Clin Transl Gastroenterol. 2020 Dec;11(12):e00264. doi: 10.14309/ctg.0000000000000264.
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.
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.
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.
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.
DCL-101 是一种新型的药丸准备，其组成与标准的 4L 聚乙二醇电解质溶液（PEG-ELS）完全相同，并将盐包裹在内，同时给予 PEG 3350 作为无味的口服溶液。本研究的目的是比较 DCL-101 与 4L PEG-ELS 在准备接受结肠镜检查的门诊患者中的安全性、口感和耐受性，次要目的是评估疗效。
这是一项多中心、随机、研究者盲法、2 期临床试验，纳入 45 名接受门诊结肠镜检查的成年患者。患者按 2:1 随机分为 DCL-101（队列 1 为 3L；队列 2 为 4L）或 4L PEG-ELS 组，均采用分剂量给药。安全性在 3 次治疗后门诊就诊时评估。耐受性采用劳伦斯肠道准备耐受性问卷和梅奥诊所肠道准备耐受性问卷进行测量。疗效由专家中心读者根据渥太华肠道准备质量量表、波士顿肠道准备量表和 Aronchick 量表进行评估，评估时对治疗方案设盲。
两种 DCL-101 剂量的口感和耐受性均优于 4L PEG-ELS。所有不良事件均为 1 级，3 种方案之间的不良事件无显著差异。3 种治疗方法的疗效无显著差异，定义为中心阅读的渥太华肠道准备质量量表、波士顿肠道准备量表或 Aronchick 评分。根据现场内镜医生的判断，没有不充分的准备。
DCL-101 药丸准备是一种新颖的策略，可极大改善 PEG-ELS 溶液的口感和耐受性，同时具有与 4L PEG-ELS 分剂量溶液相当的安全性和疗效。
