Potentiation of the antihyperalgesic effects of topically applied diclofenac by concomitant use of topical lidocaine
- Conditions
- Healthy volunteers
- Registration Number
- EUCTR2004-005127-17-AT
- Lead Sponsor
- pharmed holding GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Healthy volunteers of male and female sex.
Age 19 – 45 years.
BMI between 19 and 26 kg/cm2 .
Volunteer is healthy according to the results of the medical examination and without relevant medical problems.
Volunteer is able to understand and sign the Informed Consent.
Volunteer is able to participate in the entire study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Known sensitivity against Diclofenac or Lidocaine.
Participation in a study within the last 3 months.
Donation of blood within the last 8 weeks.
Use of any OTC medication within the last 3 days.
Use of Diclofenac or Lidocaine containing medications within the last 2 weeks.
Abuse of alcohol, drugs or drugs of abuse.
Blodd pressure (seated) lower then 90/65 or higher then 135/90 mmHg
Smoker, more than 20 cigarettes a day.
Chronic diseases in the anamnesis or acute sickness.
Any relevant skin disturbances or diseases.
Pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to investigate, whether Diclofenac and Lidocaine in combination have a stronger effect on the reduction of pain perception than Diclofenac or Lidocaine in identical concentrations alone.;Secondary Objective: ;Primary end point(s): not applicable
- Secondary Outcome Measures
Name Time Method