NCT01615510

Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models

Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models of: 1) Cold and Mechanical Hyperalgesia Evoked by Topical High-concentration Menthol , 2) Heat and Mechanical Hyperalgesia by Capsaicin.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

MOR-NRI like Tapentadol are expected to reduce signs and symptoms of central sensitisation besides effectively reducing pain intensity in pain. Human pain surrogate models can serve in this proof-of-concept study to further elucidate this assumption.

Detailed description

To evaluate exploratory the antihyperalgesic effect of a single dose of Palexia® IR (Tapentadol) in two human experimental models of 1) cold and mechanical (pinprick) hyperalgesia after topical application of menthol at high-concentration \[40%\] and 2) of heat and mechanical (pinprick) hyperalgesia by topical applied capsaicin \[0.6%\] in comparison to placebo. Therefore, cold, heat and mechanical hyperalgesia and allodynia will be determined by parameters of the Quantitative Sensory Testing (QST). These parameters are cold and heat pain thresholds, mechanical pain threshold and sensitivity as well as dynamic mechanical allodynia. Further, the areas of dynamic mechanical allodynia and pinprick-hyperalgesia will be determined at each timepoint of QST-assessement.

Conditions

• Pain
• Hyperalgesia
• Allodynia

Interventions

Type	Name	Description
DRUG	Tapentadol immediate release	100 mg, single administration
DRUG	placebo	placebo, single administration

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-06-08
• Last updated: 2022-09-14

Locations

1 site across 1 country: Germany