Randomized Study of Botulinum Toxin Type A for Achalasia

This study is ongoing, but not recruiting participants.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	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

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Esophagus Disorders

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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

No publications provided

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 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

achalasia
gastrointestinal disorders
rare disease

Additional relevant MeSH terms:

Gastrointestinal Diseases
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases

Botulinum Toxins
Therapeutic Uses
Esophageal Achalasia
Esophageal Diseases
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009