Randomized Study of Botulinum Toxin Type A for Achalasia

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004416
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: April 2001
  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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 18, 1999
Last Updated: March 24, 2015
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 Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
IncobotulinumtoxinA
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

ClinicalTrials.gov processed this record on July 27, 2016