Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients

Novartis0 个研究点目标入组 100 人开始时间: 2002年12月1日最近更新: 2012年4月30日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 100
主要终点: Mean GH and IGF-I at baseline, week 12, 24 and 48

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Newly diagnosed or previously untreated acromegalic patients
•Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT])
•Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

排除标准

•Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
•No evidence of pituitary adenoma on magnetic resonance imaging (MRI)
•Symptomatic cholelithiasis

结局指标

主要结局

Mean GH and IGF-I at baseline, week 12, 24 and 48

次要结局

Tumor volume at baseline, week 24 and 48
Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
Safety and tolerability at any time on treatment

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

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