We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Study of Botulinum Toxin Type A for Achalasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004416
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development
  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:


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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
Investigators
Study Chair: Pankaj Jay Pasricha University of Texas
  More Information

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
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
Last Verified: April 2001

Keywords provided by FDA Office of Orphan Products Development:
achalasia
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
onabotulinumtoxinA
abobotulinumtoxinA
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