EUCTR2011-002912-10-PL进行中（未招募）不适用
Efficacy and safety of oral Octreolin™ in patients with acromegaly who are currently receiving parenteral somatostatin analogs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •1.Adult subjects, aged 18 to 75 years old, inclusive, at screening visits
- •2.Subjects with acromegaly defined as documented evidence of GHsecreting
- •pituitary tumor that is abnormally responsive to glucose who
- •are currently receiving somatostatin analog.
- •3.Subjects able and willing to comply with the requirements of the
- •4.Subjects able to swallow capsules
- •5.Subjects able to understand and sign written informed consent to
- •participate in the study
- •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 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1.Symptomatic cholelithiasis
- •2.Received pituitary radiotherapy within ten years prior to screening
- •3.Undergone pituitary surgery within the prior 6 months
- •4.Clinically significant GI, renal or hepatic disease.
- •5.Known allergy or hypersensitivity to any of the test compounds or
- •6.Life expectancy of less than 2 years
- •7.Uncontrolled diabetes
- •8.Defects in visual fields due to optic chiasmal compression
- •9.Female patients who are pregnant or lactating
- •10.Female patients who are of childbearing potential
- •11.History of immunocompromise, including a positive HIV test result
- •(ELISA and Western blot)
- •12.History of alcohol or drug abuse
- •13.Intake of an investigational drug within 30 days before patient
- •inclusion in this study
研究者
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