NL-OMON36524
Completed
Not Applicable
Development of a nociceptive test battery - inflammatory and neuropathic pain tests. - Development of pain tests battery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 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).
Exclusion Criteria
- •\* 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;
Outcomes
Primary Outcomes
Not specified
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