Background: Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing.
Methods: Patients requiring colonoscopy were randomized (1 : 1) to receive NER1006 or SP + MC. Cleansing was assessed on the Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Scale (BBPS) using central readers. Two primary end points were assessed: overall colon cleansing success and high-quality cleansing of the right colon. Intention-to-treat (modified full analysis set [mFAS]) and per protocol (PP) analyses were performed.
Results: Of 515 patients, efficacy was analyzed in 501 (NER1006, n = 250; SP + MC, n = 251) and 379 patients (NER1006, n = 172; SP + MC, n = 207) in the mFAS and PP analyses, respectively. Non-inferiority of NER1006 vs. SP + MC was established in the mFAS for both overall cleansing (62.0 % vs. 53.8 %; = 0.04) and high-quality cleansing in the right colon (4.4 % vs. 1.2 %; = 0.03). Superiority of NER1006 was demonstrated using HCS in the PP set for overall cleansing success (68.0 % vs. 57.5 %; = 0.02) and right colon high-quality cleansing (5.2 % vs. 1.0 %; = 0.02) and using BBPS in the mFAS for overall cleansing success (58.4 % vs. 45.8 %; = 0.003) and right colon high-quality cleansing (4.0 % vs. 0.8 %; = 0.02). Mean segmental scores for 4/5 segments were higher with NER1006 ( ≤ 0.04). Both treatments were well tolerated, with more mild adverse events for NER1006 (17.0 % vs. 10.0 %; = 0.03).
Conclusions: Colon cleansing with NER1006 vs. SP + MC was non-inferior (mFAS) and superior (PP), with acceptable safety.European Clinical Trials Database (EudraCT)2014-002186-30TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 study 2014-002186-30 at https://eudract.ema.europa.eu/.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1055/a-0639-5070 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
AGA Clinical Practice Update on Screening and Surveillance in Individuals at Increased Risk for Gastric Cancer in the United States: Expert Review.
Gastroenterology
December 2024
Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, California.
Description: Gastric cancer (GC) is a leading cause of preventable cancer and mortality in certain US populations. The most impactful way to reduce GC mortality is via primary prevention, namely Helicobacter pylori eradication, and secondary prevention, namely endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM). An emerging body of evidence supports the possible impact of these strategies on GC incidence and mortality in identifiable high-risk populations in the United States.
View Article and Find Full Text PDFEfficacy of Oral Sulfate Tablet and 2 L-Polyethylene Glycol With Ascorbic Acid for Bowel Preparation: A Prospective Randomized KASID Multicenter Trial.
J Korean Med Sci
December 2024
Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
Background: Oral sulfate tablets (OSTs) are bowel preparation agents that combine oral sulfate solution and simethicone. This study compared the efficacy, tolerability, and safety of OST compared to 2 L-polyethylene glycol plus ascorbic acid (2 L-PEG/ASC).
Methods: This prospective, randomized, controlled, single-blinded, multicenter, noninferiority trial enrolled 211 healthy adults who underwent colonoscopy between May 2020 and September 2022 at 13 university hospitals.
Adequate bowel preparation of patients undergoing screening colonoscopy : Does educational status matter? A retrospective data analysis.
Wien Klin Wochenschr
December 2024
Quality Assurance Working Group, Austrian Society for Gastroenterology and Hepatology, Vienna, Austria.
Background: In order to achieve a high-quality screening colonoscopy, a high-quality bowel preparation is essential. To perform an adequate bowel cleansing patients need to understand and act on medical information, also known as health literacy. This study aimed to analyze the relationship between the patients' educational status as a proxy for health literacy and adequate bowel preparation.
View Article and Find Full Text PDFMannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial.
Dig Liver Dis
November 2024
Praxis für Gastroenterologie und Fachärztliche Innere Medizin, Im Haus der Gesundheit, Ludwigshafen am Rhein, Germany.
Background: Bowel preparation represents a significant issue to high-quality colonoscopy. Oral mannitol requires a single dose, is of low volume, and has a pleasant taste and rapid action.
Aims: This SATISFACTION study compared single-dose (same day) oral mannitol 100 g/750 mL with standard split-dose PEG-ASC2 L (MoviPrep®).
Prevention and Treatment of Neonatal Infections in Facility and Community Settings of Low- and Middle-Income Countries: A Descriptive Review.
Neonatology
November 2024
Centre for Global Child Health, Hospital for Sick Children, Toronto, Ontario, Canada.
Introduction: We present a robust and up-to-date synthesis of evidence on the effectiveness of interventions to prevent and treat newborn infections in low- and middle-income countries (LMICs). Newborn infection prevention interventions included strategies to reduce antimicrobial resistance (AMR), prevention of healthcare-associated infections (HAIs), clean birth kits (CBKs), chlorhexidine cleansing, topical emollients, and probiotic and synbiotic supplementation. Interventions to treat suspected neonatal infections included prophylactic systemic antifungal agents and community-based antibiotic delivery for possible serious bacterial infections (PSBIs).
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!