jRCT2031230524进行中（未招募）不适用
SK-5307 Phase II/III study (double-blind, parallel-group comparative study and open-label, uncontrolled extension study in subjects with acromegaly and pituitary gigantism)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 主要终点
- Change from baseline in serum IGF-1 concentration
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subjects who were diagnosed with acromegaly or pituitary gigantism and have undergone pituitary surgery at least once, refused to undergo pituitary surgery or with contraindications to pituitary surgery.
- •Subjects whose serum IGF-1 concentration is 1.3 times higher than the upper limit of normal (ULN) for age and gender at the screening test.
- •Subjects who have never used existing medications to treat acromegaly or pituitary gigantism.
- •Subjects on existing monotherapy to treat acromegaly or pituitary gigantism without any changes in the dosage and administration for 12 weeks prior to providing written informed consent.
- •Subjects who have participated in any previous clinical study of SK-5307 and received SK-5307 (excluding placebo of SK-5307).
- •Subjects deemed inappropriate by the investigator or subinvestigator.
排除标准
- •Subjects with a history of ineffectiveness of or significant intolerance for existing medications.
- •Subjects deemed unsuitable for existing monotherapy.
- •Subjects who are receiving two or more medications to treat acromegaly or pituitary gigantism at the time of the informed consent.
- •Subjects who underwent pituitary radiation therapy within 3 years prior to the screening test.
- •Subjects who underwent pituitary surgery within 12 weeks prior to the screening test.
- •Subjects with a high risk of pituitary tumor.
- •Subjects with hypersensitivity or a history of hypersensitivity to somatostatin analogue.
- •Subjects with symptomatic cholelithiasis.
结局指标
主要结局
Change from baseline in serum IGF-1 concentration
时间窗: Treatment Period I
Change from baseline in serum IGF-1 concentration at the end of Treatment Period I
Percentage of the subjects achieving serum IGF-1 concentrations within the reference ranges for age and gender
时间窗: Treatment Period II
Percentage of the subjects achieving serum IGF-1 concentrations within the reference ranges for age and gender at the end of Treatment Period II
次要结局
未报告次要终点
研究者
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