Esophageal Achalasia
Conditions
Keywords
achalasia, gastrointestinal disorders, rare disease
Brief 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.
Detailed description
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
Interventions
DRUGbotulinum toxin type A
Sponsors
University of Texas
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Outcome results
None listed