Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

Ipsen33 个研究点分布在 2 个国家目标入组 63 人开始时间: 2000年9月1日最近更新: 2020年3月31日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Ipsen
入组人数: 63
试验地点: 33
主要终点: Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:
•patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,
•patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.

排除标准

•Patient having had pituitary surgery within the previous 3 months
•Patient having received radiotherapy for acromegaly disease within the previous 36 months
•Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
•Patient having received lanreotide autogel at any time before the study

结局指标

主要结局

Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)

次要结局

Mean growth hormone (GH) levels
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Number of patients having a serum GH level at or below 2.5ng/ml
Number of patients having a serum GH level at or below 1 ng/ml
Number of patients with no or reduced clinical signs of acromegaly
Long-term safety of repeated injections of lanreotide autogel at titrated doses

研究者

发起方

Ipsen

申办方类型

Industry

责任方

Sponsor

研究点 (33)

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