Sjogren's syndromeRandomized Controlled Trial of Diclofenac Sodium Gel in Knee Osteoarthritis
Section snippets
Design Overview
This was a 12-week, randomized, double-blind, vehicle-controlled, parallel-group, multicenter trial. Following enrollment, eligible patients underwent a 1-week washout of analgesics (or at least 5 half-lives, whichever was longer) before being randomized to receive active drug or vehicle (placebo) daily for 12 consecutive weeks. Following the baseline visit, patients returned to the study site after 1, 4, 8, and 12 weeks for assessment of efficacy, safety, and compliance. Consistent with the
Patients
Of 492 randomized patients, 254 were assigned to receive DSG and 238 to receive vehicle; 82% and 75%, respectively, finished the study (Fig. 1). Demographic and baseline disease and symptom severity characteristics were similar in both groups (Table 2).
Efficacy
DSG was significantly superior to vehicle for all primary efficacy outcomes at week 12 (Fig. 2). Relative to baseline, patients treated with DSG exhibited greater mean decreases in WOMAC pain (−5.0 versus −4.0; P = 0.01), WOMAC function (−15.0
Discussion
In this 12-week trial, topical DSG was associated with significantly greater mean improvements versus vehicle in all primary efficacy outcome measures: the WOMAC pain subscale, WOMAC physical function subscale, and patient global rating of disease. Assessment of pain on movement, designated as an additional primary outcome for European regulatory purposes, also significantly favored DSG. Differences between DSG and vehicle were evident at week 1 and were maintained through week 12 on each
Acknowledgments
This study was funded by Novartis Consumer Health Inc, Parsippany, NJ. Funding of editorial support was provided by Endo Pharmaceuticals of Chadds Ford, PA. Employees of Novartis Consumer Health, Inc were involved in the study design, interpretation of results, and preparation of the manuscript. Selim A. Rachidi, MS (Novartis Consumer Health Inc), provided clinical operations support for the study. Jeffrey Coleman, MA (Complete Health Care Communications, Inc, Chadds Ford, PA), provided
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A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial
2020, Seminars in Arthritis and RheumatismCitation Excerpt :Diclofenac as a topical NSAID shows moderate efficacy, and there is evidence that it accumulates in the synovium [6]. However, to achieve efficacy, available topical NSAIDs require numerous voluminous daily applications of gel [11–14]. Clinical trials of currently approved diclofenac sodium 1% gel formulations found that up to 4 daily applications were required to demonstrate statistically significant efficacy vs placebo in subjects with knee OA [11, 12].
The relative efficacy of topical non-steroidal anti-inflammatory drugs and capsaicin in osteoarthritis: a network meta-analysis of randomised controlled trials
2018, Osteoarthritis and CartilageCitation Excerpt :Topical NSAIDs were compared to placebo in 32 RCTs. Data were not available for extraction for nine of the studies23–31 and the remaining 23 studies (6957 participants)32–54 were included in the NMA. Of these, 13 trials34,35,37–42,44,46,50,52,53 used a topical NSAID at its recommended dose/formulation and were included in the as licensed analysis.
Topical Treatment of Degenerative Knee Osteoarthritis
2018, American Journal of the Medical SciencesEfficacy of Combined Ultrasound-and-Microbubbles-Mediated Diclofenac Gel Delivery to Enhance Transdermal Permeation in Adjuvant-Induced Rheumatoid Arthritis in the Rat
2016, Ultrasound in Medicine and BiologyCitation Excerpt :To increase viscosity and keep retention of diclofenac on skin, carbopol 940 (0.4 g; First Chemical, Taipei, Taiwan) was dissolved in 99.6 mL of water and stirred 30 min at 120°C and 600 rpm. Since diclofenac sodium topical 1% gel is used to treat the joint pain of osteoarthritis (Barthel et al. 2009), 2 g of diclofenac (average molecular weight of 296.148 g/mol; Sigma-Aldrich, St. Louis, MO, USA) was dissolved in 98 mL of ethanol (≥99.5% purity; ECHO Chemical, Miaoli, Taiwan), glycerin (≥99.0% purity; ECHO Chemical) and phosphate-buffered saline (PBS; Amresco, Solon, OH, USA) at a ratio of 40:10:50 (v/v/v). Diclofenac solution (2%, 50 mL) was added to 50 mL of carbopol solution, and the diclofenac and carbopol solution was adjusted to pH 7 using 2,2′,2″-nitrilotriethanol (First Chemical) to produce 1% diclofenac in 0.2% carbopol gel (henceforth referred to “diclofenac-carbopol gel”).
This study was funded by Novartis Consumer Health, Parsippany, NJ. Funding of editorial support was provided by Endo Pharmaceuticals Inc, Chadds Ford, PA.
Dr. Barthel, Dr. Longley, Dr. Haselwood, and Dr. Altman have no financial interests to disclose. Dr. Gold is an employee of Novartis Consumer Health, Parsippany, NJ.