Abstract | BACKGROUND: Topical diclofenac diethylamine ( DDEA) 2.32% gel achieves lasting efficacy in localized pain with two applications per day, while maintaining the favorable safety profile of topical diclofenac and potentially improving convenience and patient compliance. METHODS: This randomized double-blind controlled study enrolled patients with acute ankle sprain treated with DDEA 2.32% gel two times per day (bid) (n = 80) or three times per day (tid) (n = 80) or placebo (n = 82). Efficacy (including pain and swelling) and local tolerability were evaluated during 8 ± 1 d. RESULTS: By day 5, the reduction in pain on movement (POM) (primary efficacy variable) with DDEA bid and tid (49.1 and 49.7 mm, respectively; 100-mm visual analog scale) was almost double that with placebo (25.4 mm) (P < 0.0001). In patients with severe baseline POM (≥ 80 mm), mean change in POM from baseline to day 5 with DDEA bid or tid was 30-40 mm greater than that with placebo, which was double the difference (15-20 mm) in patients with mild-moderate baseline POM (<80 mm). More than 70% of all DDEA patients experienced ≥ 50% reduction in POM between days 1 and 5 versus 21% of placebo patients (P < 0.0001). By study end (day 8), ankle swelling in patients treated with DDEA (0.3 cm) was one-third that in those treated with placebo (0.9 cm) (P < 0.0001), which had still not achieved the level of ankle joint function seen with DDEA on day 5 (P < 0.0001). At day 5, treatment satisfaction was "good" to "excellent" in almost 90% of DDEA patients but only "good" or "very good" in 23% of placebo patients (P < 0.0001). DDEA 2.32% gel was well tolerated. CONCLUSIONS:
DDEA 2.32% gel twice daily (applied in the morning and evening) was well tolerated and provided lasting relief from pain, improved function, and reduced symptomatic healing time in uncomplicated ankle sprain.
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Authors | Hans-Georg Predel, Sandra Hamelsky, Morris Gold, Bruno Giannetti |
Journal | Medicine and science in sports and exercise
(Med Sci Sports Exerc)
Vol. 44
Issue 9
Pg. 1629-36
(Sep 2012)
ISSN: 1530-0315 [Electronic] United States |
PMID | 22525762
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Administration, Topical
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Ankle Injuries
(drug therapy)
- Diclofenac
(administration & dosage, adverse effects)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Gels
- Humans
- Male
- Middle Aged
- Pain
(drug therapy)
- Pain Measurement
- Sprains and Strains
(drug therapy)
- Treatment Outcome
- Young Adult
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