OP0071
EFFICACY AND SAFETY OF DICLOFENAC DIETHYLAMINE 1.16% GEL IN THE TREATMENT OF ACUTE NECK PAIN: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
H. G. Predel 1,*B. Giannetti 2I. Burnett 3A. M. Hug 4
1Leiter des Instituts, Institut für Kreislaufforschung und Sportmedizin, Cologne, 2CRM Pharmaberatung GmbH, Rheinbach , Germany, 3Clinical Development, Novartis Consumer Health, Nyon, Switzerland, 4Novartis Consumer Health GmbH, Muenchen, Germany
Background: Neck pain (NP) is a common musculoskeletal disorder that affects up to 71% of the population at some point in their lifetime1 and is a frequent cause of discomfort. Characteristics include neck pain, often accompanied by some of the classical symptoms of inflammation. Non-steroidal anti-inflammatory drugs (NSAIDs) are used to reduce neck pain and inflammation, and thus facilitate earlier recovery and rehabilitation.
Topical diclofenac diethylamine (DDEA) 1.16% gel is an NSAID that has been clinically proven to be effective and well tolerated in the management of acute and chronic musculoskeletal conditions.2 Until now, however, no clinical data were available to support its use in the treatment of NP.
Objectives: To assess the efficacy and safety of DDEA 1.16% gel in the treatment of acute NP under 'in-use' conditions.
Methods: In a randomized, double-blind, placebo-controlled, multi-center, parallel group study, patients with NP originating from cervical joints and accompanying soft tissues (n=72; mean age 33.8 years) were randomized to treatment with DDEA 1.16% gel (2 g, 4x/day, for 5 days) or placebo. Efficacy assessments included pain-on-movement (POM; primary efficacy variable), pain-at-rest (PAR), functional neck disability index (NDI), global assessment of treatment and response to treatment (decrease in POM by 50% after 48 h). Adverse events (AEs) were recorded at every visit.
Results: The primary outcome, POM at 48 hours, was almost three times lower with DDEA 1.16% gel compared with placebo (19.5 mm vs. 56.9 mm; p<0.0001); this corresponded to a clinically-relevant 75% change from baseline with DDEA 1.16% gel compared with 23% with placebo. With DDEA 1.16% gel, all POM scores from the first assessment at 1 h through to 96 h were significantly lower than with placebo (p<0.0001). PAR and NDI scores (first assessment at 24 h) were also significantly lower with DDEA 1.16% gel when compared with placebo (p<0.0001). By Day 5, 100% of DDEA 1.16% gel patients rated treatment as ‘good’ to ‘excellent’ compared with just 19.4% of placebo patients (p<0.0001). Overall, 94.4% of DDEA 1.16% gel patients responded to treatment compared with 8.3% of placebo patients (p<0.001). Only one AE was observed (headache in the placebo group).
Conclusions: This study demonstrated that DDEA 1.16% gel is effective in rapidly reducing neck pain and restoring neck function and is well tolerated.
References: (1) Fejer R, Kyvik K, Hartvigsen J. Eur Spine J 2006; 15(6):834-848.
(2) Zacher J, Altman R, Bellamy N et al. Curr Med Res Opinion 2008; 24(4):925-950
Disclosure of Interest: H. Predel Grant / Research support from: Research support received from NovartisB. Giannetti: None DeclaredI. Burnett Employee of: Novartis Consumer HealthA. Hug Employee of: Novartis Consumer Health