A Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
研究概览
简要总结
This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Written voluntary informed consent.
- •Patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
- •Patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
- •Baseline (mean of 3 samples) GH level > 2 µg/L.
- •Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender.
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
排除标准
- 未提供
研究组 & 干预措施
Octreotide 30 mg every 21 days
Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
干预措施: Octreotide acetate 30 mg suspension (Drug)
Octreotide 60 mg every 28 days
Patients received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
干预措施: Octreotide acetate 30 mg suspension (Drug)
结局指标
主要结局
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
时间窗: Screening to end of study (Week 24)
Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.
Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)
时间窗: Screening to end of study (Week 24)
Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.
次要结局
- Change in Tumor Volume From Screening to End of Study (Week 24)(Screening to end of study (Week 24))
- Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)(Screening to end of study (Week 24))
- Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)(Week 12 and end of study (Week 24))
- Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)(End of study (Week 24))
- Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)(End of study (Week 24))