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Efficacy and safety of a new low-volume PEG with citrate and simethicone bowel preparation for pediatric elective
Giusy Russo1, Patrizia Alvisi2, Claudio Romano3
1Pediatric Gastroenterology and Liver Unit, Maternal and Child Health Department, Sapienza University of Rome, Rome, Italy.
Insights
A new low-volume polyethylene glycol (PEG) preparation, PMF104, is as effective and safe as conventional PEG-electrolyte solution (PEG-ES) for pediatric bowel cleansing. PMF104 demonstrated improved compliance, palatability, and acceptability in children aged 6-17 years.
Area of Science:
- Gastroenterology
- Pediatric Medicine
- Clinical Pharmacology
Background:
- Polyethylene glycol (PEG)-based preparations pose challenges in pediatric populations.
- Evaluating novel low-volume PEG formulations is crucial for improving pediatric bowel preparation.
Purpose of the Study:
- To compare the efficacy and safety of a new low-volume PEG preparation (PMF104) against a conventional PEG-electrolyte solution (PEG-ES) in children and adolescents.
- To assess colon cleansing, safety, tolerability, acceptability, palatability, and compliance in pediatric patients.
Main Methods:
- A multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial.
- Patients aged 2 to <18 years were randomized to receive either PMF104 or PEG-ES.
- Non-inferiority of PMF104 for colon cleansing was the primary endpoint; safety and tolerability were secondary endpoints.
Main Results:
- PMF104 was confirmed non-inferior to PEG-ES for colon cleansing in children aged >6 years and across all age groups in per-protocol and full analysis sets.
- Optimal compliance was significantly higher with PMF104 (86.1% vs. 68.4% in PPS).
- Palatability and acceptability were also superior for PMF104 compared to PEG-ES.
Conclusions:
- The new low-volume PMF104 is non-inferior to conventional PEG-ES for bowel cleansing in children aged 6-17 years.
- PMF104 offers comparable safety and tolerability to PEG-ES.
- PMF104 shows advantages in compliance, palatability, and acceptability, making it a potentially better option for pediatric use.
Abstract:
Background and study aims Currently available polyethylene glycol (PEG)-based preparations continue to represent a challenge in children. The aim of this study was to compare the efficacy and safety of a new low-volume PEG preparation with a conventional PEG-electrolyte solution (PEG-ES) in children and adolescents. Patients and methods This was a multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial, where patients were randomized between PMF104 (Clensia) and a conventional PEG-ES (Klean-Prep), and stratified by age stratum (2 to <6; 6 to < 12;12 to <18 years). The primary endpoint was to test the non-inferiority of PMF104 versus PEG-ES, in terms of colon cleansing. Safety, tolerability, acceptability, palatability, and compliance were also assessed. Efficacy endpoints were analyzed in the per protocol set (PPS) and full analysis set (FAS) and safety and tolerability endpoints in the safety set (SAF). Results Of the 356 patients enrolled, 258 were included in the PPS, 346 in the FAS, and 351 in the SAF. Non-inferiority of PMF104 was confirmed for children aged > 6 years and for all age groups in PPS and FAS, respectively. Optimal compliance was reported more frequently in the PMF104 than in the PEG-ES group, in both PPS (86.1% vs. 68.4%) and FAS (82.9% vs. 65.3%). Both preparations were equally safe and tolerable. Palatability and acceptability were considered better in the PMF104 group than in the PEG-ES group (27.1% vs. 15.3% and 15.3% vs. 3.5%, respectively). Conclusions In children aged 6 to 17 years, the new low-volume product PMF104 is non-inferior to the reference PEG-ES in terms of bowel cleansing, safety, and tolerability, with slightly better results in compliance, palatability, and acceptability.
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