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Randomized Study of Botulinum Toxin Type A for Achalasia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Randomized Study of Botulinum Toxin Type A for Achalasia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Randomized Study of Botulinum Toxin Type A for Achalasia Clinical research trials and Randomized Study of Botulinum Toxin Type A for Achalasia medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Randomized Study of Botulinum Toxin Type A for Achalasia. Randomized Study of Botulinum Toxin Type A for Achalasia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Randomized Study of Botulinum Toxin Type A for Achalasia clinical trial. Participants oftentimes recieve the finest healthcare available for their Randomized Study of Botulinum Toxin Type A for Achalasia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Randomized Study of Botulinum Toxin Type A for Achalasia  Randomized Study of Botulinum Toxin Type A for Achalasia
Randomized Study of Botulinum Toxin Type A for Achalasia
For Condition: Esophageal Achalasia
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Texas
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
PankajPasricha, Study Chair, University of Texas
Additional Information:
Study ID Numbers: 199/13308; UTMB-FDR001421,JHH-94122903,MCMASTER-FDA,UTMB-97-230,UTMB-BB,UTMB-GCRC-470
Study Start Date: January 1997
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004416
Other Esophageal Achalasia Studies:
1. Randomized Study of Botulinum Toxin Type A for Achalasia
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Randomized Study of Botulinum Toxin Type A for Achalasia
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