NCT00616551已完成3 期
Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg
研究概览
简要总结
The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be diagnosed with active acromegaly.
- •If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry.
- •If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry.
- •If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable.
- •If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age.
- •If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication.
- •The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.
排除标准
- •Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating.
- •Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry.
- •Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study
- •Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients
- •Subject who have any other condition that alters the growth hormone or IGF-1 levels.
- •Subjects with signs or symptoms related to a tumor compression of the optical chiasm.
研究组 & 干预措施
A
Experimental
干预措施: C2L-OCT-01 PR, 30 mg (Drug)
B
Active Comparator
干预措施: Octreotide acetate prolonged release, 30 mg (Drug)
结局指标
主要结局
Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg
时间窗: Days 1, 28, 42, 56 and 84
次要结局
- Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR(84 days)
研究者
研究点 (6)
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