NCT01243307已完成1 期
A Phase I, Single-centre, Multiple-dose, Placebo-controlled Crossover Study to Investigate the Pharmacodynamic Effects of CT327 (0.1% Topical Cream) on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers
Creabilis SA1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- An alteration in the peripheral sensitisation after treatment with CT327
研究概览
简要总结
The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain.
The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent
- •Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests
- •All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended
排除标准
- •Participation in other clinical studies within 3 months before screening
- •Scheduled for surgery, medical treatment or any hospital admission that would fall within the study
- •Use of strong painkillers
- •Use of any analgesic within 24 hours before start of study
- •Use of a regular course of prescribed medication and/or herbal medicine
- •The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas
- •A past history of contact dermatitis, psoriasis or keloid
- •Any clinically significant ECG abnormality at screening
- •A history of drug or other allergy that contraindicates his participation.
- •Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits).
- •Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening.
- •A known history of drug or alcohol abuse.
- •As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study.
- •Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing.
- •Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.
研究组 & 干预措施
CT327 treatment period 1
Experimental
Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2
干预措施: CT327 (or placebo) followed by placebo (or CT327) (Drug)
CT327 treatment period 2
Experimental
Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2
干预措施: CT327 (or placebo) followed by placebo (or CT327) (Drug)
结局指标
主要结局
An alteration in the peripheral sensitisation after treatment with CT327
时间窗: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days
次要结局
- The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush.(2 treatment/testing periods each lasting 4 days and separated by at least 10 days)
研究者
研究点 (1)
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