Efficacy

In a 7-day FLECTOR Patch study,
Patients with moderate-to-severe acute pain due to minor ankle sprain had significantly reduced pain beginning at Hour 41*
*The decrease in pain measured by VAS was significantly higher in the FLECTOR Patch group compared to the placebo group beginning at Hour 4 on Day 0, and continuing through Day 7.
VAS=Visual Analogue Scale. Scores range from 1 to 100 mm.
In a 7-day FLECTOR Patch study,
Patients with moderate-to-severe acute pain due to minor ankle sprain had significantly reduced pain for 7 days1
VAS=Visual Analogue Scale. Scores range from 1 to 100 mm.
  • At Day 3, FLECTOR Patch provided a 75% improvement from baseline vs 59% with placebo1
  • At Day 7, FLECTOR Patch provided an 84% improvement from baseline vs 74% with placebo1
In a separate 14-day study of patients with moderate-to-severe acute pain due to minor soft tissue injury, FLECTOR Patch provided a significant reduction in pain vs placebo.2

Joussellin É. Flector Tissugel® in the treatment of painful ankle sprain [in French]. 2003. A multicenter, randomized, placebo-controlled, parallel-group study evaluated the efficacy and tolerability of FLECTOR Patch (n=68) vs placebo patch (n=66) applied once daily in adult patients with a minor ankle sprain that occurred less than 48 hours prior to study entry, with a spontaneous pain score assessed by the patient of at least 50 mm on a VAS of 100 mm. The primary efficacy variable, pain on movement, was assessed by the patient using a VAS during the 6 hours following the first treatment application and at Days 1, 2, 3, and 7.
Jenoure PJ, Rostan A, Gremion G, et al. Multicentre, double-blind, controlled clinical study on the efficacy of diclofenac epolamine-Tissugel plaster in patients with epicodylitis [in Italian]. 1997. A double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of FLECTOR Patch (n=207) vs placebo patch (n=211) applied every 12 hours to the painful site of a minor soft-tissue injury (strain, sprain, or contusion) that occurred within 7 days of study entry with a pain-intensity score assessed by the patient of ≥5 on a categorical pain scale (from 0=no pain to 10=extreme pain). The primary efficacy end point was patient-assessed pain intensity on a visual analog scale (VAS) of 0-10 twice daily for 14 days or until pain resolution, and expressed as a proportion of the baseline pain score. Patients treated with FLECTOR Patch (n=192) experienced improved mean pain scores, 40.4% of baseline score vs patients using placebo patch (n=192) and 47.4% of baseline score vs patients using placebo patch (n=192), and 47.4% of baseline score over the course of the study (P=.009).
 
REFERENCES
1. Joussellin É. Flector Tissugel® in the treatment of painful ankle sprain [in French]. J Traumatol Sport. 2003;20:1S5-1S9.
2. Jenoure PJ, Rostan A, Gremion G, et al. Multicentre, double-blind, controlled clinical study on the efficacy of diclofenac epolamine-Tissugel plaster in patients with epicodylitis [in Italian]. Med Sport (Roma). 1997;50(3):285-292.