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

• Status: Terminated
• Trial end date: 2019-12-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Astellas Pharma Inc
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• 18 years old < Age < 75 years old with prior diagnosis of achalasia via manometry and/or radiographically

Exclusion Criteria:

• < 18 years old or > 75 years old

• History of hypertension not controlled on oral medications (blood pressure > 160/100 mm Hg)

• No prior history of hypertension with a blood pressure > 160/100 mm Hg

• History of bladder outlet obstruction

• History of angioedema

• Pregnant or breast-feeding women: Women between 18 and 40 years old who are enrolled in the study will be required to use a form of birth control during the study

• Patients currently receiving certain medications (digoxin, warfarin, any overactive bladder medications, thioridazine, flecainide, propafenone, phosphodiesterase inhibitors)

• Patients with prolonged QTc interval or risk factors to develop it:

• Baseline QTc on EKG of > 450 milliseconds

• History of additional risk factors for Torsades de Pointes (heart failure, family history of long QT syndrome)

• Concomitant medications that prolong the QTc interval: ranolazine, sotalol, dofetilide, procainamide, disopyramide, propafenone, azole antifungals, fluoroquinolones, macrolide antibiotics, HIV antiretrovirals, chemotherapy, beta-2 agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors

• Prior surgeries for achalasia

• < 2 months since last endoscopic botulinum toxin injection into LES or endoscopic dilation

• Stage 4 Chronic kidney disease (severe renal impairment with GFR 15-29 ml/min), Stage 5 Chronic Kidney disease (GFR < 15 ml/min or on dialysis)

• Childs Pugh B (moderate) or C (severe) Cirrhotic (hepatic impairment)