A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSSOVER PILOT STUDY WITH TRAMADOL TO VALIDATE TWO EXPERIMENTAL HUMAN PAIN MODELS AT THE KENDLE CLINICAL PHARMACOLOGY UNIT
- Conditions
- Neuropathic pain.10034606
- Registration Number
- NL-OMON32672
- Lead Sponsor
- Kendle International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate and implement the capsaicin-evoked cutaneous pain model at the<br /><br>Kendle Clinical Pharmacology Unit.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate and implement the cutaneous electrical stimulation pain model at<br /><br>the Kendle Clinical Pharmacology Unit.<br /><br>To investigate whether these human experimental pain models can discriminate<br /><br>the analgesic effects of a single oral dose of Tramadol 100 mg and a single<br /><br>oral dose of placebo.</p><br>