Randomized Study of Botulinum Toxin Type A for Achalasia

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

botulinum toxin type A

About this trial

This is an interventional treatment trial for Esophageal Achalasia focused on measuring achalasia, gastrointestinal disorders, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004416

First Posted

October 18, 1999

Last Updated

March 24, 2015

Sponsor

University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT00004416

Brief Title

Randomized Study of Botulinum Toxin Type A for Achalasia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2001

Overall Recruitment Status

Completed

Study Start Date

January 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Texas

4. Oversight

5. Study Description

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. Completion date provided represents the completion date of the grant per OOPD records

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Achalasia

Keywords

achalasia, gastrointestinal disorders, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Enrollment

56 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

botulinum toxin type A

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pankaj Jay Pasricha

Organizational Affiliation

University of Texas

Official's Role

Study Chair

Esophageal Achalasia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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