Efficacy

Pain relief of Diclofenac sodium 4% Spray Gel (DicloFlex®) vs. placebo in ankle distortions

Design

Double blind, prospective, multicentre, randomized, placebo-controlled, parallel-group study in 236 patients with ankle distortions and swelling ≥11 mm over 14 days

Methodology

Application of DDSG 4% tid; control of clinical symptoms and local tolerability on day 3,7,10 and 14; assessment of global efficacy and tolerability by the investigator and patient on a 4 stage ordinal scale

Results

DDSG 4% reduced swelling, spontaneous pain and pain during movement significantly better compared to placebo. DDSG 4% proved to be significantly more efficient than placebo and is well tolerated according to patient and investigator rating. Responder rates under DDSG 4% were 90% compared to 79% under placebo

Spontaneous pain reduction (%) of Diclofenac sodium 4% Spray Gel (DicloFlex®) in ankle distortions vs. placebo (n=236)

 

71% of patients show a total pain relief after 3 - 4 days of Diclofenac sodium 4% Spray Gel (DicloFlex®) treatment

Placebo-controlled clinical multicentre study to verify efficacy and safety of Diclofenac sodium 4% Spray Gel (DicloFlex®) in the treatment of ankle distortions, 2000, DS0306

Spontaneous pain reduction (verbal scale) of Diclofenac sodium 4% Spray Gel (DicloFlex®) in ankle distortions vs. placebo (n=236)

 

Spontaneous pain reduction (verbal scale) of Diclofenac sodium 4% Spray Gel (DicloFlex®) in ankle distortions vs. placebo (n=236)

67% of investigators and patients assess the efficacy of Diclofenac sodium 4% Spray Gel (DicloFlex®) as very good

Placebo-controlled clinical multicentre study to verify efficacy and safety of Diclofenac sodium 4% Spray Gel (DicloFlex®) in the treatment of ankle distortions, 2000, DS0306

 

Swelling reduction of Diclofenac sodium 4% Spray Gel (DicloFlex®) in ankle distortions vs. placebo (n=236)

Diclofenac sodium 4% Spray Gel (DicloFlex®) reduced swelling better than placebo

Placebo-controlled clinical multicentre study to verify efficacy and safety of Diclofenac sodium 4% Spray Gel (DicloFlex®) in the treatment of ankle distortions, 2000, DS0306

 

Bioavailability studies

Dermal permeation of Diclofenac sodium 4% Spray Gel (DicloFlex®) vs. Voltaren Emulgel into abdominal human skin after 8 hours

Penetration of Diclofenac sodium 4% Spray Gel (DicloFlex®) is 20 - times higher than of Voltaren Emulgel

Penetration and permeation of Diclofenac sodium 4% Spray Gel (DicloFlex®) vs. Voltaren Emulgel in human skin biopsies, 1997; 96014

 

Penetration into skin and the permeation of Diclofenac sodium 4% Spray Gel (DicloFlex®) vs. Voltaren Emulgel in abdominal human skin after 8 hours

Diclofenac sodium 4% Spray Gel (DicloFlex®) penetrates better through the skin into target tissues than Voltaren Emulgel

Penetration and permeation of Diclofenac sodium 4% Spray Gel (DicloFlex®) vs. Voltaren Emulgel in human skin biopsies, 1997; 96014

 

Bioavailability - Highlight

British Journal of Clinical Pharmacology
Favourable dermal penetration of diclofenac after administration to the skin using a novel spray gel formulation, DSG 4%, compared to oral treatment

Brunner M. et al, 1-5, 2005

This study showed for the first time that a topical product achieved higher subcutaneous tissue and muscle concentration vs. oral treatment!

Bioavailability of Diclofenac sodium 4% Spray Gel (DicloFlex®) in different tissue layers vs. Voltaren 50 mg tablets in humans (n=12)

Diclofenac sodium 4% Spray Gel (DicloFlex®) shows high concentration in target tissue and very low plasma levels

Favourable dermal penetration of diclofenac after administration to the skin using a novel spray gel formulation, Brunner M. et al, Br J Clin Pharmacol, 1-5, 2005 (9605)

Diclofenac sodium 4% Spray Gel (DicloFlex®) vs. Voltaren Emulgel

DSG 4% penetrates better into target tissues than Voltaren Emulgel

Favourable dermal penetration of diclofenac after administration to the skin using a novel spray gel formulation, Brunner M. et al, Br J Clin Pharmacol, 1-5, 2005 ; Topical skin penetration of diclofenac after single- and multiple-dose penetration, Dehghanyar P. et al, International Journal of clinical pharmacology and therapeutics, 42 (7), Jul 2004