The Effect of Acute Application of Pegvisomant Alone and in Combination With Octreotide on Endogenous GH Levels During a 6 Hour Test in Patients With Acromegaly on Constant Pegvisomant Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The decrease of endogenous growth hormone
研究概览
简要总结
The purpose of the study is to investigate the efficacy of an acute additional application of the somatostatin analogue octreotide 100µg s.c. or the dopamine agonist cabergoline 0.5mg p.o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •patients with acromegaly currently on stable pegvisomant therapy
- •patients with diabetes mellitus may be included. Glucose levels must be controlled regularly throughout the study
- •patients must not be co-treated with any other medication for acromegaly
排除标准
- •radiotherapy within the last 2 years
- •any relevant acute disease
- •history of hypersensitivity against any of the used drugs
- •pregnancy or lactation
- •abnormal baseline findings
研究组 & 干预措施
1
patients with acromegaly on stable pegvisomant therapy
干预措施: pegvisomant (Drug)
2
Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg
干预措施: combination with somatostatin analogue octreotide (Drug)
3
Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally
干预措施: combination with dopamine agonist cabergoline (Drug)
结局指标
主要结局
The decrease of endogenous growth hormone
时间窗: 6 or 9 hours
次要结局
- The course of glucose, insulin and pegvisomant during the profiles(6 or 9 hours)