NL-OMON37233已完成不适用
A study to investigate the pharmacodynamics, safety and tolerability of cutaneous capsaicin in healthy adult subjects. - Development of a nociceptive test battery - capsaicin models
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Agree to and be capable of signing an informed consent form.
- •- Healthy male and female subjects;
- •- Age: 18 to 65 years at screening (inclusive);
- •- Body mass index between 18-30 kg*m-2 (inclusive);
- •- Able to refrain from strenuous physical exercise from 48 hours prior to admission and during each stay at the CHDR clinic;
- •- Able to refrain from use of all (methyl)xanthenes (e.g. coffee, tea, cola, chocolate) from 12 hours prior to admission and during each stay at the CHDR clinic;
- •- Able to refrain from alcohol use from 24 hours prior to admission and during each stay at the CHDR clinic;
- •- Ability to communicate well with the investigator in the Dutch language; and
- •- Ability for female subjects to attend study day 0 while in the follicular phase (3-13 days after onset of menstruation).
排除标准
- •- Legal incapacity or inability to understand or comply with the requirements of the study;
- •- Clinically significant findings as determined by medical history taking, physical examination, ECG and vital signs;
- •- Hemodynamic status at screening: systolic <100 and >160 mmHg, diastolic <50 and >95 mmHg, heart rate <45 and >100 bpm measured on the non-dominant (non-leading/non-writing hand) arm;
- •- Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism), pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy, etc.) or capsaicin (eczema, etc);
- •- Pregnancy;
- •- Dark skin (Fitzpatrick skin type V or VI), wide-spread acne, tattoos or scarring on back or upper leg;
- •- Subjects indicating nociceptive tests (including capsaicin formulation) intolerable or insensitive at screening;
- •- Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening;
- •- Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic;
- •- History or clinical evidence of alcoholism or drug abuse;
- •- Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic;
- •- Use of prescription, illicit or herbal drugs within 7 days of nociceptive assessments;
- •- Use of over-the-counter medications within 3 days of nociceptive assessments; and/or
- •- Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
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