Validation of the microdialysis technique as a tool to assess local delivery of topical drugs used in the treatment of osteoarthritis of superficial joints - DicloMD

• Conditions: Healthy volunteers

• Registration Number: EUCTR2006-001784-35-AT
• Lead Sponsor: uvo research Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-03
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Non-smoking male or female subject aged between 18 and 40 years
2. Body mass index between 20 to 30 kg/m2.
3. Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mm Hg, heart rate between 50-99 beats/minute, temperature between 35.8 and 37.5°C after 5 min rest in supine position).
4. Normal laboratory values unless the investigator does not consider abnormalities to be clinically significant.
5. Written informed consent.
6. Female subjects: negative for pregnancy (as evaluated by serum ß-HCG test).

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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known history of hypersensitivity to dimethyl sulfoxide and/or diclofenac sodium (e.g. Pennsaid®, Voltaren®, Arthrotec®) and/or related drugs acetylsalicylic acid (e.g. Aspirin®, Excedrin®), ibuprofen (e.g. Motrin®), dimethyl sulfoxide (e.g. Rimso® 50).
2. Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
3. Presence of any significant physical or organ abnormality.
4. Presence of skin rashes, skin disorder, or skin conditions (e.g. dermatitis, eczema, psoriasis).
5. Significant trauma or surgery to the thigh and knee including diagnostic arthroscopy.
6. Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
7. Any clinically significant illness during the 4 weeks before this study.
8. Known skin sensitivity to topical applications.
9. Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
10. Significant or recent history of asthma (after 12 years of age).
11. Any subject with a history of drug abuse.
12. Any subject with a recent (less than 1 year) history of alcohol abuse.
13. Use of any prescription medication within 14 days preceding this study (except for hormonal contraceptives).
14. Use of Pennsaid within 30 days preceding this study.
15. Use of over-the-counter (OTC) medication within 7 days preceding this study (except for spermicidal/barrier contraceptive products).
16. Female subjects: evidence of pregnancy or lactation.
17. Any subject who has had blood drawn within 1 month preceding this study.
18. Participation in a clinical trial with an investigational drug within 30 days preceding this study.
19. Any subject who has donated blood within 1 month preceding this study.
20. Any subject who has participated as a plasma donor in a plasmapheresis program within 7 days preceding this study.
21. Subjects who are not willing to continue their regular diet during the entire study period.
22. Intolerance to venipuncture or implantation of the microdialysate probe.
23. Allergy or hypersensitivity against NSAIDs.
24. Renal disease or family history of renal disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified