Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Plasma Octreotide Level After Each Treatment Phase
研究概览
简要总结
Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM injections and increase drug levels, thereby improving efficacy of octreotide LAR for the treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in patients with acromegaly.
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
- •Diagnosis of active acromegaly based on evidence of a pituitary tumor
- •Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) < 1 ng/mL during an oral glucose tolerance test
- •Previous treatment with a stable dose of octreotide LAR for at least 3 months
- •No previous treatment with a stable dose of octreotide LAR for at least 3 months after receiving 3 months of octreotide LAR during a run-in phase prior to any other study-related activity
排除标准
- •Uncontrolled diabetes mellitus
- •Pregnant or breast feeding
- •Current gallstones
- •History of hepatic disease, except patients with < 3 X ULN LFTs indicative of hepatic steatosis
- •Past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
- •History of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous GH therapy
- •History of investigational drugs administered or received within 30 days of study entry
- •Known hypersensitivity to octreotide LAR
- •Any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor
研究组 & 干预措施
Ultrasound-guided IM injections of octreotide LAR
Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.
干预措施: Octreotide LAR 30 MG Injection (Drug)
Regular IM injections of octreotide LAR
Subjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months
干预措施: Octreotide LAR 30 MG Injection (Drug)
结局指标
主要结局
Plasma Octreotide Level After Each Treatment Phase
时间窗: 3 months
Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.
次要结局
- Serum IGF-1 Level(3 months)
研究者
John Carmichael
Co Director, Pituitary Program At Keck Medical Center
University of Southern California