Validation study: a newly developed neuropathic pain Heat-Capsaicin-Warmth (HCW) sensitization model.

Completed

• Conditions: Nerve pain; sensitivity to pain stimuli; 10034606

• Registration Number: NL-OMON34072
• Lead Sponsor: Top Institue Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Healthy male volunteers, age between 18 and 40 years, caucasian race, BMI between 18 and 27 kg/m2, non or moderate smoker (<10 per day), at screening state of health must satisfy the entry requirements.

Exclusion Criteria

Scar tissue on the anterior side of the dominant forearm, mental handicap, actual pain, history of serious allergies or allergic to gabapentin, remifentanil or capsaicin, regular/routine treatment with non-topical medications within 30 days prior to drug administration.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics:<br /><br>Size of the area of secondary hyperalgesia and tactile allodynia (von Frey and<br /><br>brush, respectively); VAS pain intensity sec and upon pinprick stimulation.<br /><br><br /><br>Safety:<br /><br>Adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>