- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004416
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 Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Pankaj Jay Pasricha, University of Texas
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophageal Achalasia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 199/13308
- UTMB-FDR001421
- JHH-94122903
- MCMASTER-FDA
- UTMB-97-230
- UTMB-BB
- UTMB-GCRC-470
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Asian Institute of Gastroenterology, IndiaUnknown
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