ABSTRACT
BACKGROUND: Approximately, 20-30% of patients with gastro-esophageal reflux disease (GERD) experience persistent symptoms despite treatment with proton pump inhibitors (PPIs). These patients may have underlying dysmotility; therefore, targeting gastric motor dysfunction in addition to acid inhibition may represent a new therapeutic avenue. The aim of this study was to assess the pharmacodynamic effect of the prokinetic agent revexepride (a 5-HT4 receptor agonist) in patients with GERD who have persistent symptoms despite treatment with a PPI. METHODS: This was a phase II, exploratory, multicenter, randomized, placebo-controlled, double-blind, parallel-group study in patients with GERD who experienced persistent symptoms while taking a stable dose of PPIs (ClinicalTrials.gov identifier: NCT01370863). Patients were randomized to either revexepride (0.5 mg, three times daily) or matching placebo for 4 weeks. Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires. KEY RESULTS: In total, 67 patients were enrolled in the study. There were no significant differences between study arms in the number, the mean proximal extent or the bolus clearance times of liquid-containing reflux events. Changes from baseline in the number of heartburn, regurgitation, and other symptom events were minimal for each treatment group and no clear trends were observed. CONCLUSIONS & INFERENCES: No clear differences were seen in reflux parameters between the placebo and revexepride groups.
Subject(s)
Benzofurans/therapeutic use , Gastroesophageal Reflux/drug therapy , Proton Pump Inhibitors/therapeutic use , Serotonin 5-HT4 Receptor Agonists/therapeutic use , Adolescent , Adult , Aged , Benzofurans/adverse effects , Double-Blind Method , Esophageal pH Monitoring , Female , Gastroesophageal Reflux/complications , Humans , Male , Middle Aged , Serotonin 5-HT4 Receptor Agonists/adverse effects , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: Constipation affects up to 50% of the elderly; this study evaluates the efficacy, safety, and tolerability of the selective 5-HT(4) agonist prucalopride in chronically constipated elderly patients. METHODS: Three hundred chronic constipation patients aged >or=65 years were randomized to prucalopride (1, 2, or 4 mg once daily) or placebo for 4 weeks. The primary endpoint was the percentage of patients with >or=3 spontaneous complete bowel movements (SCBM) per week. Secondary endpoints included the percentage with an increase of >or=1 SCBM per week, BM frequency, constipation-related symptoms, quality of life (QoL), safety, and tolerability. KEY RESULTS: More patients achieved >or=3 SCBM per week with prucalopride than with placebo. This difference was largest and significant during the first week of 4 mg prucalopride (P Subject(s)
Benzofurans/therapeutic use
, Constipation/drug therapy
, Defecation/drug effects
, Aged
, Aged, 80 and over
, Chi-Square Distribution
, Chronic Disease/drug therapy
, Double-Blind Method
, Female
, Humans
, Intention to Treat Analysis
, Male
, Quality of Life
, Treatment Outcome