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Randomized Study of Botulinum Toxin Type A for Achalasia

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: April 2001

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:

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

Estimated Enrollment: 56
Study Start Date: January 1997
Estimated Study Completion Date: March 2002
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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
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Please refer to this study by its identifier: NCT00004416

Sponsors and Collaborators
University of Texas
Study Chair: Pankaj Jay Pasricha University of Texas
  More Information Identifier: NCT00004416     History of Changes
Other Study ID Numbers: 199/13308
Study First Received: October 18, 1999
Last Updated: March 24, 2015

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

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on September 21, 2017