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Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study.
Curr Med Res Opin. 2016; 32(2):241-50.CM

Abstract

OBJECTIVE

Nonsteroidal anti-inflammatory drugs (NSAIDs) are standard therapy for osteoarthritis (OA). Topically applied NSAIDs reduce systemic exposure compared with oral NSAIDS, and European guidelines recommend their use. The NSAID diclofenac is available in a range of topical formulations. Diclofenac 1% gel and 1.5% four times daily and 2% twice daily (BID) solutions are approved to reduce pain from OA of the knee(s). The objective of this study was to investigate the efficacy and safety of diclofenac sodium 2% topical solution BID versus vehicle control solution for treating pain associated with OA of the knee.

RESEARCH DESIGN AND METHODS

A phase II, 4 week, randomized, double-blind, parallel-group, two-arm, vehicle-controlled study compared pain relief with diclofenac sodium 2% topical solution versus control (vehicle only) in patients aged 40 to 85 years with radiographically confirmed primary OA of the knee.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT01119898.

MAIN OUTCOME MEASURES

The primary efficacy outcome was change from baseline to the final visit in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes included additional WOMAC subscales and patient global assessment of OA. Treatment-emergent adverse events (TEAEs), skin irritation, and vital signs were assessed and collected throughout the study.

RESULTS

Of 260 patients randomized, 259 received ≥1 dose of study drug. Significantly greater reductions in least-squares mean (standard error) WOMAC pain scores were observed for diclofenac-treated (-4.4 [0.4]) versus vehicle-treated patients (-3.4 [0.4]) at the final visit (p = 0.040). The most commonly reported TEAEs were administration site conditions. The vehicle-treated group experienced slightly more TEAEs than the active treatment group (38.8% vs. 31.5%). No serious adverse events were reported.

CONCLUSIONS

Administration of diclofenac sodium 2% topical solution BID resulted in significantly greater improvement in pain reduction in patients with OA of the knee versus vehicle control and was generally well tolerated.

Authors+Show Affiliations

a a Sundance Clinical Research LLC , St. Louis, MO , USA.b b Horizon Pharma USA Inc. , Deerfield , IL , USA.c c College of Pharmacy, University of Illinois - Chicago , Vernon Hills , IL , USA.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26506138

Citation

Wadsworth, L Tyler, et al. "Efficacy and Safety of Diclofenac Sodium 2% Topical Solution for Osteoarthritis of the Knee: a Randomized, Double-blind, Vehicle-controlled, 4 Week Study." Current Medical Research and Opinion, vol. 32, no. 2, 2016, pp. 241-50.
Wadsworth LT, Kent JD, Holt RJ. Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Curr Med Res Opin. 2016;32(2):241-50.
Wadsworth, L. T., Kent, J. D., & Holt, R. J. (2016). Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Current Medical Research and Opinion, 32(2), 241-50. https://doi.org/10.1185/03007995.2015.1113400
Wadsworth LT, Kent JD, Holt RJ. Efficacy and Safety of Diclofenac Sodium 2% Topical Solution for Osteoarthritis of the Knee: a Randomized, Double-blind, Vehicle-controlled, 4 Week Study. Curr Med Res Opin. 2016;32(2):241-50. PubMed PMID: 26506138.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. AU - Wadsworth,L Tyler, AU - Kent,Jeffrey D, AU - Holt,Robert J, Y1 - 2015/11/17/ PY - 2015/10/28/entrez PY - 2015/10/28/pubmed PY - 2016/8/30/medline KW - Diclofenac sodium 2% topical solution KW - Efficacy KW - Knee osteoarthritis KW - Safety SP - 241 EP - 50 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 32 IS - 2 N2 - OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are standard therapy for osteoarthritis (OA). Topically applied NSAIDs reduce systemic exposure compared with oral NSAIDS, and European guidelines recommend their use. The NSAID diclofenac is available in a range of topical formulations. Diclofenac 1% gel and 1.5% four times daily and 2% twice daily (BID) solutions are approved to reduce pain from OA of the knee(s). The objective of this study was to investigate the efficacy and safety of diclofenac sodium 2% topical solution BID versus vehicle control solution for treating pain associated with OA of the knee. RESEARCH DESIGN AND METHODS: A phase II, 4 week, randomized, double-blind, parallel-group, two-arm, vehicle-controlled study compared pain relief with diclofenac sodium 2% topical solution versus control (vehicle only) in patients aged 40 to 85 years with radiographically confirmed primary OA of the knee. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01119898. MAIN OUTCOME MEASURES: The primary efficacy outcome was change from baseline to the final visit in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes included additional WOMAC subscales and patient global assessment of OA. Treatment-emergent adverse events (TEAEs), skin irritation, and vital signs were assessed and collected throughout the study. RESULTS: Of 260 patients randomized, 259 received ≥1 dose of study drug. Significantly greater reductions in least-squares mean (standard error) WOMAC pain scores were observed for diclofenac-treated (-4.4 [0.4]) versus vehicle-treated patients (-3.4 [0.4]) at the final visit (p = 0.040). The most commonly reported TEAEs were administration site conditions. The vehicle-treated group experienced slightly more TEAEs than the active treatment group (38.8% vs. 31.5%). No serious adverse events were reported. CONCLUSIONS: Administration of diclofenac sodium 2% topical solution BID resulted in significantly greater improvement in pain reduction in patients with OA of the knee versus vehicle control and was generally well tolerated. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/26506138/Efficacy_and_safety_of_diclofenac_sodium_2_topical_solution_for_osteoarthritis_of_the_knee:_a_randomized_double_blind_vehicle_controlled_4_week_study_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007995.2015.1113400 DB - PRIME DP - Unbound Medicine ER -