EUCTR2004-002849-12-GB进行中（未招募）不适用
Extension to a multicenter, randomized, crossover, open label, dose finding study to compare the safety, efficacy and PK/PD relationship of multiple doses of SOM230 (200, 400 and 600 µg b.i.d.) and doses of open label Sandostatin (100 µg t.i.d.) in acromegalic patients
ovartis Pharmaceuticals UK Ltd0 个研究点目标入组 48 人开始时间: 2005年7月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients aged between 18 and 80 years.
- •Patients must have completed all four treatment regimens in [study 2201], and achieved biochemical control (as defined above) after at least one month of SOM230 administration at any of the three doses
- •The patient did not experience any unacceptable adverse events or tolerability issues during the original SOM230 treatments.
- •Patients who entered the original protocol with diabetes mellitus may be included, but it is recommended that the glucose levels and treatment for diabetes are monitored throughout the trial. If a patient developed diabetes or glucose intolerance during [study 2201] that did not resolve following cessation of treatment with SOM230, they are not eligible for the extension protocol.
- •Karnofsky Performance Status = 60
- •Written informed consent to participate in the extension study has been obtained
- •Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the extension study, and for one month after the study has ended
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Compression of the optic chiasm causing any visual field defect.
- •Patient required a surgical intervention for relief of any sign or symptom associated with tumor compression.
- •Congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or acute myocardial infarction .
- •Symptomatic cholelithiasis.
- •Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, or alkaline phosphatase levels more than twice the upper limit of normal; or direct bilirubin more than 10% of the upper limit of normal.
- •A hypersensitivity to SOM230.
- •Abnormal clinical laboratory values considered by the Investigator or the Sponsor’s Medical Monitor to be clinically significant and which could affect the interpretation of the study results.
- •Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable and highly effective method for birth control. If oral contraception is used, the patient must have been practicing this method for at least two months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for one month after the study has ended.
- •Patients who have developed glucose intolerance or diabetes mellitus that does not resolve once SOM230 treatment is stopped.
研究者
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