Octreotide Efficacy and Safety in First-line Acromegalic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated
研究概览
简要总结
Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.
This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.
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
- •Males and females 18 and < 80 years old.
- •Recently diagnosed not previously treated patients with acromegaly.
- •Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
- •Absence of nadir suppression of the nadir of GH to < 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
- •IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
- •Tolerance shown with a test of a subcutaneous injection of octreotide
- •Written Informed Consent before any procedure specific to the study. Inclus
排除标准
- •Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
- •Compression of optic chiasm that produces any impairment of field of vision.
- •Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
- •Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
- •Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
- •Pregnant women
- •History of alcohol or drug abuse in the six months prior to the inclusion visit.
- •Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent
- •Intake of an investigational drug during the study and 30 days before patient inclusion in this study
- •Other protocol-defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
octrotide
干预措施: Octreotide (Drug)
结局指标
主要结局
To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated
时间窗: at baseline, weeks 12, 24, 48
To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated
时间窗: at baseline, weeks 12, 24, 48
次要结局
- To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.(at baseline, weeks 12, 24, 48)
- To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms(at baseline, weeks 12, 24, 48)