NCT00700518已完成1 期
A Phase I Trial of the Pharmacodynamic Dose Response to Topical Trinitrate in Patients With Raynaud's Phenomenon
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Investigate vascular responses to topical Glyceryl Trinitrate versus placebo in patients with Raynaud's using laser Doppler imaging to measure blood flow
研究概览
简要总结
The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female volunteers aged between 18 and 50 inclusive
- •Subject has idiopathic RP (patient may have undifferentiated connective tissue disease with positive ANA) diagnosed for more than two (2) years
- •If a female, subject must be non-pregnant and non-lactating
- •The subject has provided written informed consent prior to admission to this study
排除标准
- •History of clinically relevant medical illnesses (not considering RP) that in the Investigator's opinion may jeopardize subject's safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, unstable hypertension, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically mediated disorders
- •History in the past five (5) years of drug or alcohol abuse
- •History in the past five (5) years of vascular migraine or other chronic severe headache
- •History in the past five (5) years of autonomic neuropathy or postural hypotension
- •Unwilling or unable to comply with the restrictions outlined in the protocol
- •Current use of smoking cessation treatment, including nicotine patches
- •History of drug allergies, anaphylaxis or laryngeal oedema, including allergy to GTN, propylene/ethylene glycol or common moisturizing creams
- •Use of any nitrate medication or any phosphodiesterase inhibitor within three (3) days prior to or intended use one (1) day following each dosing with study drug
- •Currently treated for hypertension
- •Currently receiving treatment for prevention and/or treatment of RP
- •Use of any investigational medication within 30 days prior to dosing with study medication or scheduled to receive an investigational drug other than during the course of this study
- •Open skin lesions or pathological condition (including, but not limited to, infection) in the area where the study medication is to be applied
- •Use of topical corticosteroid to the hand or fingers within 10 days of treatment with study drug
- •Withdrawal of consent at any time during the study
- •Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study
- •Previously enrolled in the study
研究组 & 干预措施
1.
Placebo Comparator
placebo cream applied to 2 adjacent fingers on non-dominant hand one time
干预措施: placebo cream (Drug)
2
Active Comparator
0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand
干预措施: Glyceryl Trinitrate (Drug)
3
Active Comparator
1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
干预措施: Glyceryl Trinitrate (Drug)
4
Active Comparator
1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time
干预措施: Glyceryl Trinitrate (Drug)
5
Active Comparator
2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
干预措施: Glyceryl Trinitrate (Drug)
结局指标
主要结局
Investigate vascular responses to topical Glyceryl Trinitrate versus placebo in patients with Raynaud's using laser Doppler imaging to measure blood flow
时间窗: 6 visits no less than 10 hours between visits
次要结局
- Evaluate the dose proportionality of the microvascular response to topical Glyceryl Trinitrate(6 visits no less than 10 hours between visits)
- Compare the systemic versus topical effect of Glyceryl Trinitrate on vascular response.(6 visits no less than 10 hours between visits)
研究者
研究点 (1)
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