Randomized Study of Botulinum Toxin Type A for Achalasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供