Randomized Study of Botulinum Toxin Type A for Achalasia
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.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||January 1997|
|Estimated Study Completion Date:||March 2002|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004416
|Study Chair:||Pankaj Jay Pasricha||University of Texas|