drugset / Trial / NCT02666846
Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model
RandomizedCrossoverQuadruple-blindTreatment
Summary
This is a randomised, double blind, cross over clinical study in healthy human volunteers (including pharmacokinetic \[PK\] sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a model of UV-induced inflammatory pain.
Timeline
- Start
- 2015-03
- Primary completion
- 2015-05
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 2 % | Topical |
| Subject | Diclofenac | Other / unclassified | 4 % | Topical |
| Subject | Diclofenac | Other / unclassified | 50 mg | Topical |
| Subject | Ibuprofen | Small molecule | 10 % | Topical |
| Subject | Ibuprofen | Small molecule | 400 mg | Topical |
| Comparator | Menthol | Small molecule | 7 % | Topical |
| Comparator | Methyl Salicylate | Small molecule | 15 % | Topical |
Indications
No indication recorded.