ACTRN12612000129886尚未招募2 期
Randomised controlled trial of eight weeks treatment with Atorvastatin versus conventional treatment (Prednisolone) as an agent of induction of disease remission measured by the paediatric disease activity index (PCDAI) in children with newly diagnosed crohn’s disease aged 8-17 years
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 8 Years 至 17 Years（—）
- 性别
- All
入选标准
- •Male or females aged 8 to 17 years
- •-Diagnosis of crohn’s diease confirmed on clinical,radiological,endoscopic and/or histological criteria and yet to receive treatment
排除标准
- •- Age <8 or > than 17
- •- Previously treated CD
- •- Newly diagnosed CD but already commenced any form of therapy for induction of remission including any form of steroid therapy.
- •- Any underlying chromosomal disorders eg Down’s syndrome, Turner’s syndrome
- •-Any underlying autoimmune diagnosis eg juvenile arthritis, connective tissue disease, coeliac disease, type 1 diabetes mellitus, addison’s disease, hypothyroidism, hyperthyroidism, polyglandular endocrinopathy.
- •- Primary bone disorder eg osteogenesis imperfecta
- •- A secondary chronic medical diagnosis that may have an impact on linear growth and bone health
- •- Previous adverse reaction to statins
- •- Current pregnancy or sexually active and not using a medically acceptable form of birth control. (All girls who are menarchal or > 14 years of age will need to undego a pregnancy test before being eligible for the study).
- •- History of clinically significant organic or psychiatric disease or findings on physical examination, which in the opinion of the Investigator would prevent the patient from completing the study.
- •- Ongoing use of oral corticosteroid for a different medical condition prior to diagnosis
- •- Ongoing use of immunomodulators eg azathioprine, methotrexate; biologics eg anti TNF therapy for a different medical condition (to exclude patients with another known chronic inflammatory condition)
- •- Ongoing use of growth hormone, sex steroid, thyroxine and/or steroid replacement (hydrocortisone, prednisolone, dexamathasone) for an underlying endocrine diagnosis (to exclude conditions like growth hormone deficiency, hypopituitarism)
- •- Ongoing use of cyclosporine, fibrates, CYP3A4 inhibitors, itraconazole, HIV protease inhibitors (concurrent medication absolutely contraindicated with atovarstatin).
- •- AST or ALT > 2 x upper limit of normal from investigations performed in the last 4 weeks.
研究者
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