drugset / Trial / NCT03654066

Botox or Botox With Esophageal Dilation in Patients With Achalasia

NCT03654066

Phase 4 Enrolling by invitation 50 enrolled Vanderbilt University Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

Achalasia is a rare esophageal motility disorder. Treatment of achalasia is aimed toward palliation of symptoms. These include botox injections to the lower esophageal sphincter (LES), pneumatic dilation, surgical myotomy, and per-oral endoscopic myotomy (POEM). Botox injections are frequently used for patients that have significant comorbidities. The primary aim of this study is to assess symptomatic response of patient with achalasia to esophageal dilation and botox injection to the LES compared to standard therapy of only botox injection.

Timeline

Start
2019-05-13
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic Other

Indications