The effect of the M1-selective telenzepine on esophageal acid exposure in healthy volunteers.

In order to study the effect of the new M1-selective antimuscarinic compound telenzepine on physiological esophageal acid exposure, ten healthy volunteers underwent a 24-hour esophageal pH-monitoring during a one week treatment with either tablets containing telenzepine 3 mg nightly or placebo in a double-blind cross-over trial. Side-effects were recorded, and stimulated salivary output was assessed. Using a cut-off pH less than 4, under telenzepine a significant reduction of reflux time and of maximum reflux duration was observed in supine position. Using a cut-off pH less than 2, reflux time was reduced during and after meals, number of refluxes was decreased during meals, and esophageal clearance was improved with telenzepine in supine position. Telenzepine reduced salivary output significantly on day 4 and on day 7. From the results it can be concluded that the drug is not contraindicated in peptic ulcer patients with heartburn. As telenzepine reduces gastroesophageal reflux time during and after meals and in supine position it may be tried as adjuvant treatment in esophageal reflux disease.

RCT Entities:   Population Interventions Outcomes