Randomized Study of Botulinum Toxin Type A for Achalasia - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

January 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004416 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Randomized Study of Botulinum Toxin Type A for Achalasia

Official Title ^ICMJE

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Esophageal Achalasia

Intervention ^ICMJE

Drug: botulinum toxin type A

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004416

Responsible Party

Study ID Numbers ^ICMJE

199/13308, UTMB-FDR001421, JHH-94122903, MCMASTER-FDA, UTMB-97-230, UTMB-BB, UTMB-GCRC-470

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

University of Texas

Investigators ^ICMJE

Study Chair:

Pankaj Jay Pasricha

University of Texas

Information Provided By

FDA Office of Orphan Products Development

Verification Date

April 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP