NCT02807233已完成不适用
Observational, Multicenter, Cross-sectional, Observational Study to Evaluate the Effectiveness in Routine Clinical Practice of Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) for the Treatment of Acromegaly: SOMACROL Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 115
- 试验地点
- 39
- 主要终点
- Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with acromegaly in daily clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Men or women aged ≥ 18 years
- •Diagnosed with acromegaly
- •Receiving treatment with ATG 120 mg at extended dosing intervals (> 4 weeks) for at least six months before the study visit.
- •Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available.
- •Able to sign the informed consent form for study participation.
排除标准
- •Received radiation therapy treatment in the last six months.
- •Active participation in another clinical study.
- •Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form.
- •Pregnancy or breastfeeding for female patients.
- •No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months.
结局指标
主要结局
Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.
时间窗: Day 1
次要结局
- Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks.(Day 1)
- Percentage of subjects whose dosing regimen has been changed in the six months before the study.(Day 1)
- Preference for self-administered injections or administration in an outpatient clinic by a medical professional.(Day 1)
- Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.(Day 1)
- EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.(Day 1)
- Variations between theoretical and real treatment compliance for non-medical reasons.(Day 1)
- Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.(Day 1)
- Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months.(Day 1)
研究者
研究点 (39)
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