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.

Condition	Treatment or Intervention
Esophageal Achalasia	Drug: botulinum toxin type A

Further Study Details: 

Expected Total Enrollment:  56

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Study chairs or principal investigators

Pankaj Jay Pasricha,  Study Chair,  University of Texas   

Study ID Numbers:  199/13308; UTMB-FDR001421; JHH-94122903; MCMASTER-FDA; UTMB-97-230; UTMB-BB; UTMB-GCRC-470
Record last reviewed:  April 2001
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004416
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08