Oral prucalopride in children with functional constipation

Area of Science:

• Pediatric Gastroenterology
• Pharmacology
• Clinical Therapeutics

Background:

• Functional constipation is a common pediatric condition.
• Prucalopride, a 5-HT4 receptor agonist, has gastrointestinal prokinetic properties.
• Evaluating pediatric formulations is crucial for effective treatment.

Purpose of the Study:

• To assess the pharmacokinetics, efficacy, safety, and tolerability of prucalopride oral solution in children aged 4-12 years with functional constipation.
• To characterize the drug's behavior in a pediatric population.

Main Methods:

• A single oral dose pharmacokinetic study (0.03 mg/kg) in 38 children.
• An 8-week open-label extension study with daily dosing (0.01-0.03 mg/kg) in 37 children.
• Evaluation of bowel movement frequency, stool consistency, and adverse events.

Main Results:

• Prucalopride exhibited predictable pharmacokinetics with limited variability, similar to adults but with lower systemic exposure.
• Treatment led to improved bowel movement frequency (6.8/week), normal stool consistency, and reduced fecal incontinence.
• 70% of participants experienced mild/moderate adverse events, with none leading to discontinuation.

Conclusions:

• Prucalopride oral solution demonstrates a favorable pharmacokinetic, efficacy, and tolerability profile in pediatric patients with functional constipation.
• The drug appears safe and effective for this age group, supporting its use in clinical practice.