Randomized Study of Botulinum Toxin Type A for Achalasia

University of Texas56 enrolled

Overview

OBJECTIVES: I. Compare the efficacy of two doses of botulinum toxin in the treatment of achalasia. II. Compare the safety of these two doses in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, dose response study. Patients are randomized to one of two treatment arms; each arm receives a different dose of botulinum toxin type A. All patients undergo a flexible upper gastrointestinal endoscopy. Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants. Some patients may receive a second treatment, depending on response and/or time of relapse. Patients are followed daily for 7 days, then every 1-6 months for 1-2 years after treatment. Completion date provided represents the completion date of the grant per OOPD records

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Esophageal Achalasia

Interventions

botulinum toxin type ADRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Diagnosis of achalasia by esophageal manometry and upper endoscopy * Symptomatic including dysphagia, regurgitation, etc. * No esophageal ulcers, Barrett's esophagus, significant esophagitis, or esophageal varices --Patient Characteristics-- * Hematopoietic: Platelet count at least 50,000/mm3 * Hepatic: PT no greater than 3 seconds No severe hepatic problems * Renal: No severe renal problems * Cardiovascular: No recent myocardial infarction No unstable angina No decompensated congestive heart failure * Pulmonary: No severe pulmonary disease with dyspnea at rest * Other: No altered mental status No serious systemic disease Not pregnant

Data from ClinicalTrials.gov

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