Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2l-OCT-01 PR, Administered Intra Muscularly Every 4, 5 or 6 Weeks in Acromegalic Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.
研究概览
简要总结
The purpose of this study is to assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Population A
Based on the dose of their previous Sandostatin-LAR treatment, Population A will receive 10 or 20 mg of C2L-OCT-01 PR at 5-week intervals.
干预措施: C2L-OCT-01 PR, 10 or 20 mg (Drug)
Population B
Population B, naive patients and patients who have stopped their treatment with prolonged release octreotide for at least 12 weeks, will receive 20 mg C2L-OCT-01 PR at 5-week intervals.
干预措施: C2L-OCT-01 PR, 20 mg (Drug)
结局指标
主要结局
To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.
时间窗: 28-day screening period followed by a 48 to 52 week treatment period and concluding with a end of study visit at 56, 57 or 58 weeks.
次要结局
- To assess biological and clinical activity of C2L-OCT-01 PR by examining the percentage of patients with mean growth hormone (GH) <2.5 ng/ml.(Screening, Visits 1 through 11, and End of Study Visit.)
- To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the mean changes from baseline in GH and IGF-1 concentrations.(Screening, Visits 1 through 11, and End of Study Visit.)
- To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the acromegaly severity index and patient's health status scores.(Screening, Visit 1 through 11, and End of Study Visit.)
- To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size.(Screening, Visit 6 and End of Study Visit.)