Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study

Achalasia Clinical Trial

Official title: Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study

Status Terminated

Clinical Trial Summary

This study evaluates whether a medication called mirabegron is better than placebo (sugar pill) in helping patients with achalasia swallow better. Each patient will receive either mirabegron or the placebo for 4 weeks followed by the opposite medication. Each patient will complete several surveys and undergo several tests to determine if the mirabegron is helping reduce the pressures in the esophagus (swallowing tube).

Clinical Trial Description

Achalasia is characterized by incomplete or absent relaxation of the lower esophageal sphincter (LES) and loss of esophageal peristalsis which leads to dysphagia. Standard of care for achalasia includes endoscopic management (dilation and injection of injection of botulinum toxin) and surgery, however both of these options carry procedural risks, may lose efficacy over time and many patients are not appropriate candidates for these treatment options. Unfortunately, there are limited oral medications for patients with achalasia. Mirabegron is an oral beta-3 agonist currently FDA approved for overactive bladder that works by relaxing the bladder muscles. Beta-3 receptors have also been identified in the LES with stimulation leading to LES relaxation in preclinical studies. Through a proof of concept pilot study, the investigators aim to evaluate the effect of mirabegron in patients with achalasia via high resolution manometry and a validated dysphagia scale. ;

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

• NCT number: NCT03411252
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Terminated
• Phase: Early Phase 1
• Start date: February 15, 2018
• Completion date: December 15, 2019