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Clinical Trials/NL-OMON34385
NL-OMON34385
Completed
Not Applicable

Development of a nociceptive test battery - acute pain tests - Development of pain tests battery

Centre for Human Drug Research0 sites20 target enrollmentTBD
ConditionsPain10034606

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Centre for Human Drug Research
Enrollment
20
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

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;
  • \* 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 (paraesthesia, etc.);
  • \* Pregnancy
  • \* History or clinical evidence of alcoholism or drug abuse;
  • \* 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.

Outcomes

Primary Outcomes

Not specified

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