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Randomized Study of Botulinum Toxin Type A for Achalasia

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ClinicalTrials.gov Identifier: NCT00004416
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

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 or disease Intervention/treatment Phase
Esophageal Achalasia Drug: botulinum toxin type A Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 56 participants
Primary Purpose: Treatment
Study Start Date : January 1997
Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004416

Sponsors and Collaborators
University of Texas
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Study Chair: Pankaj Jay Pasricha University of Texas
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ClinicalTrials.gov Identifier: NCT00004416    
Other Study ID Numbers: 199/13308
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: April 2001
Keywords provided by FDA Office of Orphan Products Development:
gastrointestinal disorders
rare disease
Additional relevant MeSH terms:
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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