NCT00725348已完成2 期
An Open-Label, Multi-Center Pilot Trial to Assess the Efficacy and Safety of Oral R115866 in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis
Stiefel, a GSK Company2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2004年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- PASI Scores
研究概览
简要总结
This is a study of a new oral drug used for the treatment of psoriasis. All subjects will get active medication, there is no placebo arm.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of non-childbearing potential (at least 2 years post-menopausal or undergone successful surgical sterilization at least 1 year before inclusion)
- •Presence of moderate to severe plaque psoriasis with a PASI of at least 5
排除标准
- •Pustular, guttate or other non-plaque forms of psoriasis or psoriatic arthritis
- •Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
- •History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
- •Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males
- •Use of vitamin A (>1000 µg/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroidal anti-inflammatory drugs, non-potassium-sparing diuretics
- •Previous use of any systemic immunomodulatory therapy (biologicals) or psoriasis vaccine
- •Use of other systemic therapy for psoriasis (e.g. PUVA, systemic steroids, cyclosporin A, methotrexate, retinoids) within four weeks prior to Visit 2
- •Use of UV therapy or excessive UV exposure or topical therapy for psoriasis other than bland emollients within two weeks prior to Visit 2
研究组 & 干预措施
A
Experimental
R115866
干预措施: Talarozole (Drug)
结局指标
主要结局
PASI Scores
时间窗: Various Visits
次要结局
未报告次要终点
研究者
研究点 (2)
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