Randomized Study of Botulinum Toxin Type A for Achalasia

Esophageal Achalasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004416
• Other study ID #: 199/13308
• Secondary ID: UTMB-FDR001421JH
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: January 1997
• Est. completion date: March 2002

Study information

• Verified date: April 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Achalasia

Intervention

Drug:
• botulinum toxin type A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas