Randomized Study of Botulinum Toxin Type A for Achalasia

The University of Texas System (UT)

Status: Completed

Conditions: Esophageal Achalasia

Treatments: Drug: botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT00004416

MCMASTER-FDA

JHH-94122903

UTMB-FDR001421

UTMB-97-230

199/13308

UTMB-BB

UTMB-GCRC-470

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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