Open Label Extension Study Evaluating the Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, Administered Intra Muscularly Every 6, 5 or 4 Weeks in Acromegalic Patients

Ambrilia Biopharma, Inc.6 个研究点分布在 6 个国家目标入组 63 人开始时间: 2007年10月最近更新: 2009年6月4日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Ambrilia Biopharma, Inc.
入组人数: 63
试验地点: 6
主要终点: Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study.

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

The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.

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

入选标准

•Subjects who have completed the 24-week C2L-OCT-01 PR-301 study

排除标准

•Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating
•Subjects who have experienced any clinically significant adverse event related to study medication in C2L-OCT-01 PR-301 study
•Subjects with uncontrolled Diabetes type II
•Subjects with signs or symptoms related to a tumor compression of the optical chiasm
•Subjects with symptomatic cholelithiasis

结局指标

主要结局

Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study.

时间窗: Up to 96 weeks

次要结局

To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.(Up to 96 weeks)
Compare plasma concentrations of C2L-OCT-01 PR.(First 6 months)

研究者

发起方

Ambrilia Biopharma, Inc.

申办方类型

Industry

研究点 (6)

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