NL-OMON36524已完成不适用
Development of a nociceptive test battery - inflammatory and neuropathic pain tests. - Development of pain tests battery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 each nociceptive test until dismissal from the CHDR clinic;
- •* Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic;
- •* Ability to communicate well with the investigator in the Dutch language.
- •* Ability for female subjects to attend study days 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) or pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, etc.);
- •* Pregnancy;
- •* Dark skin, wide-spread acne, tattoos or scarring on back or forearm;
- •* Subjects indicating nociceptive tests intolerable at screening, achieving tolerance at >70% of maximum input intensity for any somatic tasks;
- •*Non-responders to UVB, determined by a MED > 1321 mJ/cm^2;
- •* 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;
- •* Sun-bathing or sun-bed use 2 weeks prior to screening and not able to abstain from sun-bathing or sun-bed use from screening until end of last study day;
- •* Use of prescription, illicit or herbal medication within 7 days of nociceptive assessments;
- •* Use of over-the-counter medications within 3 days of nociceptive assessments.
- •* Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
研究者
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