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.

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. - Pharmacodynamic study with tapentadol PR and pregabalin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42611

Enrollment

Registered

2015-09-02

Start date

2015-09-11

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathische pijn Neuropathic pain Pain due to nerve damage

Interventions

Tapentadol (Palexia Retard) Pregabalin (Lyrica) Capsaicin

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
* pain scores (on a 0 to 100 NRS) after an intradermal capsaicin injection * Area (in cm2) of secondary mechanical hyperalgesia after intradermal capsaicin injection * Area (in cm2) of vascular flare after an intradermal capsaicin injection	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)