NCT01295060终止3 期
PHASE IIIB, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF AN 84-MG OCTREOTIDE SUBCUTANEOUS HYDROGEL IMPLANT IN SUBJECTS WITH ACROMEGALY
Endo Pharmaceuticals0 个研究点目标入组 12 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 主要终点
- Long term safety and tolerability of the Octreotide Implant
研究概览
简要总结
This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide Implant in patients that were previously treated with an Octreotide implant.
详细描述
Evaluation on the long-term safety and tolerability, including local tolerability of the implant site, of the 84-mg octreotide hydrogel implant in subjects with acromegaly who had been successfully treated with the 84-mg octreotide hydrogel implant in the Phase III study IP107-001.
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
- •Currently enrolled in the Extension Phase of Study IP107-001 and received at least one 84-mg octreotide hydrogel implant prior to enrollment OR previously enrolled in the Extension Phase of Study IP107-001 and currently taking lanreotide or octreotide.
- •Subjects who have been successfully treated with the 84-mg octreotide hydrogel implant in Study IP107
- •In the opinion of the Investigator; subject has no unstable chronic medical conditions and no clinically significant findings that would preclude subject's participation in the study.
- •Subjects must be able to communicate, provide and sign written informed consent, and be willing to participate and comply with study requirements.
排除标准
- •Pituitary surgery less than 3 months prior to enrollment into this study
- •Liver disease (eg, cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of ALT, AST [level >2× normal] or direct bilirubin [level >1.5× normal])
- •Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV)
- •Acute myocardial infarction within 3 months of Screening
- •Uncontrolled diabetes defined as having an HbA1c ≥9%
- •Symptomatic cholelithiasis
- •History of drug or alcohol abuse
- •Received any investigational drug or participated in another clinical trial except for study IP107 001 within 30 days of enrollment into this study
- •Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time prior to enrollment into this study
- •Receiving pegvisomant, dopamine agonist or other therapy in combination with somatostatin to control GH or IGF-1 levels prior to enrollment into this study
- •History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, any other severe coexisting or, terminal systemic disease that limits life expectancy, or may interfere with the conduct of the study, or subjects who are incarcerated in penal institutions or are committed to mental institutions
- •Women who are pregnant or lactating. For females of childbearing potential, a positive pregnancy test prior to enrollment, or an unwillingness to use accepted forms of reliable birth control for study duration (including bilateral tubal ligation, use of oral contraceptives, double barrier methods [diaphragm with spermicidal gel or condoms with contraceptive foam], Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence). Pregnancy tests are not required (indicate "n/a") for males, or for females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy with bilateral oophorectomy)
- •An unwillingness on the part of a male subject to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom and spermicide and another form of contraception (eg, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study
研究组 & 干预措施
Octreotide Implant
Experimental
干预措施: Octreotide (Drug)
结局指标
主要结局
Long term safety and tolerability of the Octreotide Implant
时间窗: every 3 months for up to 2 years
Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site
次要结局
- Evaluate the long term efficacy of the Octreotide Implant(every 3 months for up to 2 years)
研究者
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