RESUMO
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 1âL PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SPâ+âMC) in day-before dosing. METHODS: Patients requiring colonoscopy were randomized (1 : 1) to receive NER1006 or SPâ+âMC. 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, nâ=â250; SPâ+âMC, nâ=â251) and 379 patients (NER1006, nâ=â172; SPâ+âMC, nâ=â207) in the mFAS and PP analyses, respectively. Non-inferiority of NER1006 vs. SPâ+âMC was established in the mFAS for both overall cleansing (62.0â% vs. 53.8â%; Pâ=â0.04) and high-quality cleansing in the right colon (4.4â% vs. 1.2â%; Pâ=â0.03). Superiority of NER1006 was demonstrated using HCS in the PP set for overall cleansing success (68.0â% vs. 57.5â%; Pâ=â0.02) and right colon high-quality cleansing (5.2â% vs. 1.0â%; Pâ=â0.02) and using BBPS in the mFAS for overall cleansing success (58.4â% vs. 45.8â%; Pâ=â0.003) and right colon high-quality cleansing (4.0â% vs. 0.8â%; Pâ=â0.02). Mean segmental scores for 4/5 segments were higher with NER1006 (Pâ≤â0.04). Both treatments were well tolerated, with more mild adverse events for NER1006 (17.0â% vs. 10.0â%; Pâ=â0.03). CONCLUSIONS: Colon cleansing with NER1006 vs. SPâ+âMC 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/.
