Randomized Study of Botulinum Toxin Type A for Achalasia
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|ClinicalTrials.gov Identifier: NCT00004416|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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 or disease||Intervention/treatment|
|Esophageal Achalasia||Drug: botulinum toxin type A|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Study Start Date :||January 1997|
|Estimated Study Completion Date :||March 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004416
|Study Chair:||Pankaj Jay Pasricha||University of Texas|