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

NCT03411252 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-03-24

No results posted yet for this study

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).

Conditions

  • Achalasia

Interventions

DRUG

Mirabegron 50 MG

Myrbetriq (Mirabegron) tablet

DRUG

Placebo

Sugar pill manufactured to mimic Mirabegron

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2019-12-15
Completion
2019-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411252 on ClinicalTrials.gov