Presented at the 2012 AAPM Annual Meeting « Back

Randomized, Parallel-Group, Open-Label, Dose-Finding Study Evaluating the Efficacy of Diclofenac Sodium Topical Solution in Soft-Tissue Pain of the Heel

Srinivas Nalamachu, MD, nalamachu@yahoo.com¹, Donna Ruck, ARNP¹, Amanda M. Valdivieso, MA¹, Ritvik Bansal¹, Mitchell F. Dorris, DPM¹, (1) International Clinical Research, Leawood, Kansas

Introduction: Plantar fasciitis is a common cause of heel pain, often most painful in the morning. This 4-week, single-site, randomized, parallel, open-label study evaluated the efficacy and safety of diclofenac sodium topical solution (TDiclo) in heel pain. Methods: Patients applied 20 (Group 1) or 40 (Group 2) drops of TDiclo to the heel twice daily, titrated to three times daily if needed. The primary endpoint was change in pain severity from baseline based on a visual analog scale (VAS) (scale, 1-100). Global assessment of treatment satisfaction was also evaluated. Adverse events (AEs) and relationships to treatment were recorded. Written informed consent was obtained from patients prior to enrollment, and the protocol was approved by the investigator’s Institutional Review Board. Results: Forty patients (20 in each group) with clinical evidence of soft-tissue heel pain, including plantar fasciitis, were enrolled (mean age 52.6 y [range 18-75 y]; 75% female). Mean change in VAS from baseline to final visit was 11.7 (-31%). Most patients (82.5%) were very satisfied or satisfied with treatment. Overall, 65% and 30% of patients in Groups 1 and 2, respectively, titrated to 3-times-daily dosing. AEs were reported in 6 (0.2%) patients; all were considered mild, and 1 (dryness at application site) was considered by the investigator to be probably related to TDiclo. Conclusion: TDiclo administered 2–3 times daily was effective and well tolerated in these patients with heel pain. Additional, placebo-controlled studies are needed in this patient population.

Funding: Technical editorial and writing support for the preparation of this abstract was provided by Amanda McGeary, MS, Synchrony Medical, LLC, West Chester, PA. Funding for this support was provided by Mallinckrodt, Inc., a Covidien Company, Hazelwood, MO.