Table 1.

Overview of randomized, double-blind clinical trials of diclofenac sodium topical solution

Reference	Interventions	Duration	Patientsa (n)	Description of patients	Primary efficacy variable(s)	Other efficacy variables
Bookman et al23	TDiclo Vehicle control Placebo control	4 weeks	248	Men and women (18–80 years) Primary, radiologically verified OA of the knee At least moderate pain	WOMAC pain	WOMAC physical function WOMAC stiffness score PGA WOMAC pain on walkingb
Roth and Shainhouse24	TDiclo Vehicle control	12 weeks	326	Men and women (40–85 years) Primary, radiologically verified OA of the knee Pain flare	WOMAC pain WOMAC physical function PGA	WOMAC stiffness WOMAC pain on walkingb
Baer et al25	TDiclo Vehicle control	6 weeks	216	Men and women (40–85 years) Primary, radiologically verified OA of the knee Pain flare	WOMAC pain WOMAC physical function PGA	WOMAC stiffness WOMAC pain on walkingb
Simon et al26	TDiclo Oral diclofenac TDiclo + oral diclofenac Vehicle control Placebo control	12 weeks	775	Men and women (40–85 years) Primary, radiologically verified OA of the knee Pain flare	WOMAC pain WOMAC physical function POHA	WOMAC stiffness PGA
Tugwell et al27	TDiclo Oral diclofenac	12 weeks	622	Men and women (40–85 years) Primary, radiologically verified OA of the knee At least mild symptoms of OA	WOMAC pain WOMAC physical function PGA	WOMAC stiffness WOMAC pain on walkingb Percent responders (OMERACT-OARSI criteria)

^aNotes: Number of patients included in safety analysis;

^bFirst question in the WOMAC pain subscale.

Abbreviations: DMSO, dimethyl sulfoxide; OA, osteoarthritis; WOMAC, Western Ontario and McMaster Universities; OMERACT, Outcome Measures in Arthritis Clinical Trials; OARSI, Osteoarthritis Research Society International; PGA, patient global assessment; POHA, patient overall health assessment; TDiclo, diclofenac sodium topical solution with DMSO.