NCT01117298已完成3 期
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study
Sanjay Gandhi Postgraduate Institute of Medical Sciences4 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Daily frequency, duration and severity of Raynaud's phenomenon
研究概览
简要总结
Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between the ages of 18 years and 65 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma) despite being on vasodilator therapy. Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor. Patients with a history of at least 4 attacks per week during two-week pre-trial period even with treatment with other vasodilators will be recruited. Patients fulfilling the diagnostic criteria of scleroderma (as per American College of Rheumatology criteria) or having presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias)will be invited to participate in the study.
排除标准
- •Patients with:
- •Symptomatic orthostatic hypotension,
- •Evidence of current malignancy,
- •History of sympathectomy,
- •Upper extremity deep vein thrombosis or lymphedema within 3 months,
- •Recent surgical procedure requiring general anesthesia,
- •Acute Myocardial Infarction, unstable angina, strokes and transient ischemic attacks within the past three months,
- •Use of any investigational drug within 30 days of the study sessions,
- •Use of medications that might interfere with tadalafil like nitrates and alpha adrenergic blockers that have vasoactive effects, and patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole, erythromycin, itraconazole, and grapefruit juice,
- •Patients taking alcohol,
- •Patients with bleeding disorders
- •Significant active peptic ulceration,
- •Current pregnancy,
- •Current breast-feeding.
研究组 & 干预措施
Tadalafil
Experimental
干预措施: Tadalafil (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Daily frequency, duration and severity of Raynaud's phenomenon
时间窗: Baseline and 8 weeks
Appearance or healing of digital ulcers
时间窗: Baseline and 8 weeks
次要结局
- Improvement in health assessment questionnaire(Baseline and 8 weeks)
- Improvement in scleroderma specific health assessment questionnaire(Baseline and 8 weeks)
- Improvement in quality of life(Baseline and 8 weeks)
- Improvement in biomarkers of endothelial dysfunction(Baseline and 8 weeks)
- Improvement in flow mediated dilatation(Baseline and 8 weeks)
研究者
研究点 (4)
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