Randomized Study of Botulinum Toxin Type A for Achalasia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	FDA Office of Orphan Products Development University of Texas
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004416

Purpose

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	Intervention
Esophageal Achalasia	Drug: botulinum toxin type A

MedlinePlus related topics: Botox Esophagus Disorders

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	56
Study Start Date:	January 1997

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004416

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of Texas

Investigators

Study Chair:

Pankaj Jay Pasricha

University of Texas

More Information

Study ID Numbers:	199/13308, UTMB-FDR001421, JHH-94122903, MCMASTER-FDA, UTMB-97-230, UTMB-BB, UTMB-GCRC-470
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004416
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

achalasia
gastrointestinal disorders
rare disease

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Botulinum Toxins
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Rare Diseases
Esophageal Achalasia
Esophageal Diseases
Botulinum Toxin Type A
Cardiospasm
Achalasia

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009