NCT00994214终止2 期
Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 109
- 试验地点
- 23
- 主要终点
- Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
研究概览
简要总结
The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IGF-1 ≥1.3 x upper limit normal (ULN)
- •Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
- •Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.
排除标准
- •The patient has received long acting somatostatin analogues within 6 months of study entry
- •The patient has undergone radiotherapy at any time prior to study entry
- •The time between pituitary surgery (if any) and study entry is less than 6 weeks
- •The patient suffers from macroadenoma with visual field defects due to chiasmatic compression
研究组 & 干预措施
BIM 23A760 1 mg
Experimental
干预措施: BIM 23A760 (Drug)
BIM 23A760 2 mg
Experimental
干预措施: BIM 23A760 (Drug)
BIM 23A760 4 mg
Experimental
干预措施: BIM 23A760 (Drug)
BIM 23A760 6 mg
Experimental
干预措施: BIM 23A760 (Drug)
结局指标
主要结局
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
时间窗: At Month 6
次要结局
- Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1(At Month 1)
- Number of Subjects Reported Adverse Events During the Study(Up to Visit 10 (An average of 6.5 Months))
- Percentage Change in Ring Finger Circumference(Baseline (Day 1) and Month 6)
- Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6(0-3 hr on Baseline (Day 1) and Months 1, 3 and 6)
- Changes in IGF-1(Baseline (Day 1) and Month 6)
研究者
研究点 (23)
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