2024-512888-31-00招募中4 期
A registry-based, open-label, randomized study to investigate quality-of-life with Plenadren compared with Cortison in participants aged 16-80 with newly diagnosed primary adrenal insufficiency (CORTAD)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- HRQoL score.
研究概览
简要总结
Differences in health-related quality of life (HRQoL) scores in patients receiving Plenadren and conventional Cortisone at time of diagnosis and 1, 6, and 12 months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 16-80 years
- •Established PAI according to the diagnostic criteria as specified above.
- •Participants must be recently diagnosed, specifically treated with glucocorticoid replacement therapy for less than 31 days prior to inclusion to secure treatment naivety.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test performed at the time of screening.
- •Participants must be capable of giving signed informed consent
排除标准
- •High dose glucocorticoid therapy for other disease during last three months prior to screening.
- •Ongoing treatment for active malignant disease.
- •Severe hepatic or renal disease.
- •Sever psychiatric disease.
- •Chronic abuse of alcohol or drug abuse.
- •Current pregnancy, and if the participant plan to become pregnant during the 12 months of study participation.
- •Known hypersensitivity to the active substance or any of the excipients.
- •Participation in another blinded clinical study involving an investigational medicinal product within 1 month prior to study inclusion.
结局指标
主要结局
HRQoL score.
HRQoL score.
次要结局
- Blood pressure, body weight, waist circumference, body mass index, cholesterols, glucose, insulin, HOMA index.
- Hair cortisol level, Salivary cortisol day curves, 24 h urine cortisol and metabolites.
- Sleep diary, actigraphy, sleep radar.
- Cognitive testing and biomarker for brain plasticity (BDNF) in serum.
- Bone mineral density, body composition and bone markers
- Adverse events, Serious adverse events, Adrenal crisis symptoms and treatment.
研究者
Eystein Husebye
Scientific
Helse Bergen HF
研究点 (14)
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