Mo1031 IMPROVED HIGH-QUALITY COLON CLEANSING WITH 1L NER1006 VERSUS 2L POLYETHYLENE GLYCOL + ASCORBATE OR ORAL SULFATE SOLUTION

2019 ◽  
Vol 89 (6) ◽  
pp. AB415
Author(s):  
Daniel C. Baumgart ◽  
Jürgen Gschossmann ◽  
Bharat Amlani ◽  
Alessandro Repici
Keyword(s):  
Polyethylene Glycol ◽  
Sulfate Solution ◽  
High Quality ◽  
Colon Cleansing

scholarly journals High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

2020 ◽  
Vol 08 (05) ◽  
pp. E628-E635
Author(s):  
Michael S. Epstein ◽  
Robert Benamouzig ◽  
Juha Halonen ◽  
Raf Bisschops
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Combined Treatment ◽  
Sulfate Solution ◽  
Lesion Detection ◽  
High Quality ◽  
Post Hoc Analysis ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Post Hoc

Abstract Background and study aims Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol (PEG) NER1006 versus 2 + 1 L PEG + ascorbate (2LPEG) or 1 + 2 L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0–4 (high-quality = HCS 3–4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29 % vs. 20 %; P < 0.001) and HCS 4 scores (20 % vs. 17 %; P = 0.007) versus 2LPEG/OSS. More polyps (678 versus 585) and adenomas (397 versus 331) were detected with NER1006 (N = 517) versus 2LPEG/OSS (N = 520). In all neoplasia-positive patients, with increasing minimal per-patient neoplasia multiplicity from 1 to 10, NER1006 numerically improved MPP (difference ± SE: 0.48 ± 0.24 to 3.89 ± 3.37) and MAP (0.47 ± 0.26 to 7.50 ± 9.00) versus 2LPEG/OSS. Conclusions Low-volume NER1006 enhances high-quality cleansing versus medium-volume 2LPEG or OSS, individually and when combined. NER1006 may consequently facilitate the detection of multiple neoplasia in patients.

scholarly journals Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution

2019 ◽  
Vol 51 (12) ◽  
pp. 1671-1677
Author(s):  
Alessandro Repici ◽  
Emmanuel Coron ◽  
Prateek Sharma ◽  
Cristiano Spada ◽  
Milena Di Leo ◽  
...  
Keyword(s):  
Sulfate Solution ◽  
High Quality ◽  
Colon Cleansing

scholarly journals Bowel preparation with 1L polyethylene glycol and ascorbate NER1006 doubles the chance to detect three or more adenomas in overweight or obese males

2021 ◽  
Vol 09 (09) ◽  
pp. E1324-E1334
Author(s):  
Michael Epstein ◽  
Juha Halonen ◽  
Prateek Sharma
Keyword(s):  
Logistic Regression ◽  
Polyethylene Glycol ◽  
Randomized Clinical Trials ◽  
Sulfate Solution ◽  
Colorectal Adenomas ◽  
Success Rates ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Dosing Regimens ◽  
Split Dosing

Abstract Background and study aims Men have more colon cleansing failures, colorectal adenomas, and colorectal cancers than women. We analyzed whether 1-liter (1 L) polyethylene glycol (PEG) NER1006 improves high-quality (HQ) colon cleansing and adenoma detection in males versus two mid-volume alternatives. Patients and methods The analysis of 1028 adult patients in two randomized clinical trials was performed. Adenoma detection and HQ cleansing were compared for overnight split dosing regimens with NER1006 (n = 513) versus combined oral sulfate solution or 2 L PEG + ascorbate (OSS/2 L PEG) (n = 515). Analyses included males versus females, overweight or obese (OO) males versus lean males, and NER1006 versus OSS/2 L PEG. In male patients, the adenoma detection rate of at least 3 (ADR3 +) was predicted with multiple logistic regression and statistical comparisons used the two-sided t-test. Results ADR3 + was greater in males versus females (10.7 % [56/524] versus 5.8 % [29/504]; P = 0.004) despite comparable adequate cleansing success rates (93.2 % [479/514] versus 93.0 % [466/501]; P = 0.912) and more HQ-scores in females (41.6 % [1069/2570] versus 45.3 % [1134/2505]; P = 0.008). ADR was almost twice as high in OO versus lean males (43.4 % [184/424] versus 23.1 % [21/91]; P < 0.001). Multivariate logistic regression predicted ADR3 + detection to be twice as likely in OO males using NER1006 versus OSS/2 L PEG (odds ratio (95 % confidence interval [CI]) = 2.049 (1.082–3.973); P = 0.030) and 90 % more likely in all males (1.902 (1.045–3.526); P = 0.037). In males, including OO males, NER1006 attained more HQ-scores per trial than OSS or 2 L PEG (P ≤ 0.017 for all comparisons). Conclusions NER1006 predicted the detection of more males for frequent surveillance than OSS/2 L PEG.

scholarly journals Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial

Endoscopy ◽  
2018 ◽  
Vol 51 (01) ◽  
pp. 60-72 ◽  
Author(s):  
Raf Bisschops ◽  
Jonathan Manning ◽  
Lucy Clayton ◽  
Richard Ng Kwet Shing ◽  
Marco Álvarez-González ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
High Volume ◽  
Polyp Detection ◽  
Right Colon ◽  
High Quality ◽  
Phase 3 ◽  
Total N ◽  
Colon Cleansing ◽  
Parallel Group

Abstract Background Polyethylene glycol (PEG)-based bowel preparations are effective cleansers but many require high-volume intake. This phase 3, randomized, blinded, multicenter, parallel-group, central reader-assessed study assessed the 1 L PEG NER1006 bowel preparation vs. standard 2 L PEG with ascorbate (2LPEG). Methods Patients undergoing colonoscopy were randomized (1:1:1) to receive NER1006, as an evening/morning (N2D) or morning-only (N1D) regimen, or evening/morning 2LPEG. Cleansing was assessed using the Harefield Cleansing Scale (HCS) and the Boston Bowel Preparation Scale (BBPS). Primary end points were overall bowel cleansing success and high-quality cleansing in the right colon. Modified full analysis set (mFAS) and per protocol (PP) analyses were performed. Mean cleansing scores were analyzed post hoc. Results Of 849 randomized patients, efficacy was analyzed in the following patient numbers (mFAS/PP): total n = 822/670; N2D n = 275/220; N1D n = 275/218; 2LPEG n = 272/232. mFAS established noninferiority. PP showed superiority for N2D on overall success (97.3 % vs. 92.2 %; P = 0.014), and for N2D and N1D on right colon high-quality cleansing (N2D 32.3 % vs. 15.9 %, P < 0.001; N1D 34.4 % vs. 15.9 %, P < 0.001) vs. 2LPEG. Using HCS, N2D and N1D attained superior segmental high-quality cleansing (P ≤ 0.003 per segment). N2D showed superior mean segmental HCS scores (P ≤ 0.007 per segment). Both N2D and N1D achieved superior mean overall (P < 0.001 and P = 0.006) and right colon BBPS scores (P < 0.001 and P = 0.013). N2D demonstrated superior right colon polyp detection (P = 0.024). Adherence, tolerability, and safety were comparable between treatments. Conclusions NER1006 is the first low-volume preparation to demonstrate superior colon cleansing efficacy vs. standard 2LPEG with ascorbate, with comparable safety and tolerability. European Clinical Trials Database (EudraCT)2014-002185-78TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 trial 2014-002185-78 at https://eudract.ema.europa.eu/

Efficacy of Two Regimens for Colon Cleansing Using Polyethylene Glycol 4000: A Randomized Open Label Trial

2021 ◽  
Vol 58 (12) ◽  
pp. 1119-1123
Author(s):  
Phan Thi Hien ◽  
Vu Huu Thoi ◽  
Nguyen Thu Ha ◽  
Nicolas Kalach
Keyword(s):  
Polyethylene Glycol ◽  
Open Label ◽  
Polyethylene Glycol 4000 ◽  
Colon Cleansing ◽  
Open Label Trial

Novel sulfate tablet PBK‐1701TC versus oral sulfate solution for colon cleansing: A randomized phase 3 trial

2019 ◽  
Vol 35 (1) ◽  
pp. 29-36
Author(s):  
Hyo‐Joon Yang ◽  
Dong Il Park ◽  
Soo‐Kyung Park ◽  
Chang Kyun Lee ◽  
Hyo Jong Kim ◽  
...  
Keyword(s):  
Sulfate Solution ◽  
Phase 3 ◽  
Colon Cleansing
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