Neuropathic pain.
Conditions
Interventions
On day 1 and 2 100 mg of tramadol will be administered .
Capsaicin pain model
In the capsaicin pain model is a small amount of capsaicin injected under the
skin. In this survey, 100 * g (microgram
Sponsors
Kendle International
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male, at least 18 years of age, inclusive; 2. Subjects must voluntarily sign a written informed consent agreement; 3. Good health, based upon the results of medical history, physical examination, vital signs, ECG, and laboratory tests.
Exclusion criteria
Exclusion criteria: 1. Subject suffering from any (chronic) pain condition and/or diabetes; 2. Any dermatological or neurological condition that may interfere with the assessments done in this study; 3. Presence or history of epilepsy, asthma or bronchitis; 4. Hypersensitivity, intolerance or allergy to relevant drug 5. Hypersensitivity, intolerance or allergy to capsaicin (incl. Capsicum peppers) 6. Subjects who have used prescription medication within 1 week or 5 drug half-lives (whichever is the longer) prior to Day 1; 7. Subjects who have used OTC medication including analgetics within 48 hours prior to Day 1; 8. Positive serology test results for hepatitis B, C or HIV; 9. Presence or history of alcoholism or drug abuse; 10. Positive alcohol breath test result; 11. Positive drug screen result; 12. Participation in an investigational drug study within 3 months prior to Day 1; 13. Unsuitable to participate in the study for any reason in the opinion of the PI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and implement the capsaicin-evoked cutaneous pain model at the Kendle Clinical Pharmacology Unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and implement the cutaneous electrical stimulation pain model at the Kendle Clinical Pharmacology Unit. To investigate whether these human experimental pain models can discriminate the analgesic effects of a single oral dose of Tramadol 100 mg and a single oral dose of placebo. | — |
Countries
Netherlands
Outcome results
None listed