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Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of Texas |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004416 |
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 |
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Esophageal Achalasia |
Drug: botulinum toxin type A |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 56 |
Study Start Date: | January 1997 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
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: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004416 History of Changes |
Health Authority: | United States: Federal Government |
achalasia gastrointestinal disorders rare disease |
Gastrointestinal Diseases Rare Diseases Achalasia Cardiospasm Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases |
Botulinum Toxins Esophageal Disorder Esophageal Achalasia Esophageal Diseases Peripheral Nervous System Agents Botulinum Toxin Type A |
Gastrointestinal Diseases Anti-Dyskinesia Agents Physiological Effects of Drugs Neuromuscular Agents Pharmacologic Actions Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases |
Botulinum Toxins Therapeutic Uses Esophageal Achalasia Esophageal Diseases Peripheral Nervous System Agents Botulinum Toxin Type A Central Nervous System Agents |