Randomized Study of Botulinum Toxin Type A for Achalasia

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Esophageal Achalasia

Clinical Trial Details

NCT number	NCT00004416
Study type	Interventional
Source	FDA Office of Orphan Products Development
Contact
Status	Completed
Phase	N/A
Start date	January 1997
Completion date	March 2002

View Details

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