Randomized Study of Botulinum Toxin Type A for Achalasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2002-03-31

Brief Summary

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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.

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Detailed Description

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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

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Esophageal Achalasia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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botulinum toxin type A

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No