Status:
TERMINATED
Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Achalasia
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 pl...
Detailed 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 includ...
Eligibility Criteria
Inclusion
- 18 years old \< Age \< 75 years old with prior diagnosis of achalasia via manometry and/or radiographically
Exclusion
- \< 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)
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03411252
Start Date
February 15 2018
End Date
December 15 2019
Last Update
March 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107