Prucalopride is no more effective than placebo for children with functional constipation.

Background & Aims: Prucalopride is a selective, high-affinity agonist of the 5-hydroxytryptamine (serotonin) receptor 4 that enhances motility in the gastrointestinal tract. We performed a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of prucalopride in children (6 months to 18 years old) with functional constipation.

Methods: Children with functional constipation, based on the Rome III criteria, were given prucalopride (children ≤ 50 kg were given a 0.

Effect of prucalopride on the pharmacokinetics of oral contraceptives in healthy women.

Background: Prucalopride is a selective, high-affinity, 5-hydroxytryptamine 4 (5-HT4) receptor agonist, which is approved for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. Women of childbearing potential, many of whom will be using oral contraceptives, comprise a large proportion of patients seeking medical therapy for constipation.

Objective: The aim of this study was to evaluate the effect of prucalopride on the absorption and steady-state pharmacokinetics of oral contraceptives in healthy women.

Oral prucalopride in children with functional constipation.

Background And Objectives: Prucalopride is a selective, high-affinity 5-HT4 receptor agonist with gastrointestinal prokinetic activities. The aim of this study was to evaluate the pharmacokinetics, efficacy, safety, and tolerability of prucalopride oral solution in children, ages 4 years or older to 12 years or younger, with functional constipation.

Methods: A single oral dose of 0.

Assessment of the cardiac safety of prucalopride in healthy volunteers: a randomized, double-blind, placebo- and positive-controlled thorough QT study.

Aims: To assess steady-state effects of therapeutic and supra-therapeutic doses of prucalopride on the QT interval using a novel design involving a parallel placebo group with nested crossover for positive control.

Methods: A double-blind, double-dummy, placebo- and active-controlled study was conducted in 120 healthy male and female volunteers (NCT00903747). Volunteers were randomized to receive prucalopride 2-10 mg once daily (therapeutic and supratherapeutic doses, respectively) (group 1), placebo with 400 mg moxifloxacin on day 1 (group 2a), or placebo with moxifloxacin on day 15 (group 2b).

The effect of antifungal treatment on the vaginal flora of women with vulvo-vaginal yeast infection with or without bacterial vaginosis.

Antibacterial therapy may enhance the risk of symptomatic vulvo-vaginal candidosis in susceptible women. We addressed the question whether oral antifungal treatment for vulvo-vaginal candidosis also influences the bacterial vaginal microflora. One hundred and forty-two patients with a culture-proven acute episode of recurrent vulvo-vaginal candidosis (RVC) were treated with fuconazole according to the ReCiDiF regimen (induction dose of 600 mg orally per week followed by 200 mg per week) or with a single dose of 200 mg pramiconazole, a new potent oral triazole.