Randomized Study of Botulinum Toxin Type A for Achalasia

• Status: Completed
• Trial end date: 2002-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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