Randomized Study of Botulinum Toxin Type A for Achalasia
botulinum toxin type A
Deglutition Disorders+7
+ Digestive System Diseases
+ Esophageal Diseases
Treatment Study
Summary
Study start date: January 1, 1997
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.56 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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