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Randomized Study of Botulinum Toxin Type A for Achalasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Texas
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004416
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: April 2001
History of Changes
  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: Primary Purpose: Treatment

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00004416     History of Changes
Other 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
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
achalasia
gastrointestinal disorders
rare disease

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013