Translational trial to explore the pharmacodynamic effects of multiple oral dose administrations of tapentadol PR, pregabalin, and combinations of both in an intradermal capsaicin hypersensitization model in healthy subjects.

Completed

• Conditions: neuropathische pijn; Neuropathic pain; Pain due to nerve damage

• Registration Number: NL-OMON42611
• Lead Sponsor: Grunenthal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

healthy male subjects
- 18-55 yrs, inclusive
- BMI: 20.0-30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* pain scores (on a 0 to 100 NRS) after an intradermal capsaicin injection<br /><br><br /><br>* Area (in cm2) of secondary mechanical hyperalgesia after intradermal<br /><br>capsaicin injection<br /><br><br /><br>* Area (in cm2) of vascular flare after an intradermal capsaicin injection</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Average cutaneous blood flow (quantified in arbitrary units) after an<br /><br>intradermal capsaicin injection.<br /><br><br /><br>* Mean pain intensity (0 to 100 VAS) during a 2-minute cold pressor test.<br /><br><br /><br>* Safety and tolerability of the drug combinations.</p><br>