Effect of flupirtine on experimental hyperalgesia in humans

Completed

• Conditions: ormal skin sensitivity and experimentally-evoked hyperalgesia; Disturbances of skin sensation; Signs and Symptoms

• Registration Number: ISRCTN64819760
• Lead Sponsor: niversity of Heidelberg (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Healthy volunteers, age 18 - 65 years
2. Negative pregnancy test (on day of respective visit, female)
3. Written informed consent
4. Clinical laboratory values within the normal range

Exclusion Criteria

1. Any history of allergy or drug hypersensitivity
2. Any acute or chronic disease
3. Alcohol or drug abuse
4. Use of any medication within 1 day prior to study onset or, in case of any intake of medication during the last 6 weeks, the wash-out period prior to inclusion was at least less than 5 times the corresponding half-life of the medication taken (incl. dermatological applications; except contraceptives)
5. Dermatological, psychiatric or neurological disorder
6. Blood coagulation disorder
7. Chronic or severe liver disease (hep. encephalopathy, cholestase)
8. Myasthenia gravis
9. Acute or recently resolved tinnitus
10. Use of analgesics or CNS active drugs
11. Participation in any clinical study within 30 days prior to this study
12. Any relevant deviation in clinical or laboratory assessment
13. Known hypersensivity to flupirtine and its derivatives
14. Known hypersensitivity to histamine
15. Skin lesions at the test areas
16. Pregnant or nursing women

Study & Design

• Study Type: Interventional
• Study Design: Not specified