Clinical trial NCT02666846
Conditions: Pain
Keywords: UVB Pain Model PK Topical NSAIDs
Sponsor: Futura Medical Developments Ltd.
Start date: 2015-03-01; Completion date: 2015-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Detailed description:
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, 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. The study will consist of 3 cohorts of subjects (n=20 subjects per cohort). Subjects of each cohort will receive test and reference products (no reference product for Cohort 3) of one investigational medicinal product (IMP) and a placebo.

Test Products:

Cohort 1: Ibuprofen, TIB200 gel (10%, w/w) Cohort 2: Diclofenac, DCF100 gel (2% or 4%, w/w) Cohort 3: Methyl-salicylate and Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate to Menthol)

Reference Products:

Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w), Ibuprofen, Nurofen, oral tablet (400 mg) Cohort 2: Voltaren Emulgel (2%), Voltarol oral tablet (50 mg)

Placebo:

All Cohorts:Test product matching vehicle gel.

Pharmacodynamic tests and PK blood draws will be performed at: pre-dose, 1, 2, 4, and 6 hours post dose for all treatment cohorts and treatment days (PK blood sampling in up to 6 subjects per cohort only).

Safety will be evaluated by the incidence of local and systemic treatment-emergent adverse events (TEAEs) reported after each treatment. Safety assessments will also include vital signs, 12-Lead Electrocardiograms (ECGs), laboratory tests and a physical examination at Screening and the Follow-up visit.

Arms: arm 1: All Cohort 1 participants: TIB200 gel (10%, w/w ibuprofen) arm 2: All Cohort 1 participants: Nurofen Max Strength gel (10%, w/w ibuprofen) arm 3: All Cohort 1 participants: Nurofen oral tablets (2 x 400 mg ibuprofen) arm 4: All Cohort 1 Participants: TIB200 matching placebo gel arm 5: All Cohort 2 Participants: DCF100 gel (2% w/w diclofenac) arm 6: All Cohort 2 Participants: DCF100 gel (4% w/w diclofenac) arm 7: All Cohort 2 Participants: Voltaren Emulgel (2% diclofenac) arm 8: All Cohort 2 Participants: Voltarol oral tablet (50 mg - diclofenac) arm 9: All Cohort 2 Participants: DCF100 matching placebo gel arm 10: All Cohort 3 Participants: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol) arm 11: All Cohort 3 Participants: SPR300 matching placebo gel
Interventions: intervention 1: Ibuprofen intervention 2: Diclofenac intervention 3: Methyl-salicylate / Menthol intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: