NCT00004416

Randomized Study of Botulinum Toxin Type A for Achalasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (planned)
• Sponsor: University of Texas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Esophageal Achalasia

Interventions

Type	Name	Description
DRUG	botulinum toxin type A

Timeline

• Start date: 1997-01-01
• Completion: 2002-03-01
• First posted: 1999-10-19
• Last updated: 2015-03-25