BACKGROUND: The @entity17338 topical patch 1.3% (DETP) is indicated for topical treatment of @entity12761 due to minor strains, @entity6475 , and contusions. This exploratory, multicenter, open-label study evaluated effectiveness and safety of DETP in @entity1 with @entity615 . METHODS: @entity1 aged >=  18 years with @entity12761 due to nonradicular back strain with an average @entity158 intensity of >=  4 (0 = no @entity158 , 10 = @entity158 as bad as you can imagine) entered a 3-day observation/washout period and completed daily diary modified Brief Pain Inventory assessments. At baseline, @entity1 with an average @entity158 intensity of >=  4 started DETP treatment (q12h). @entity1 were treated for 7 or 14 days, depending on investigator and @entity1 assessment of @entity158 resolution. Primary endpoint was mean change from baseline to end of treatment in average @entity158 intensity. Key secondary endpoints included changes from baseline in least, worst, and current @entity158 scores and Beck Depression Inventory(  ) II scores. @entity1 and investigators assessed patch satisfaction and global @entity158 relief. RESULTS: In 123 enrolled @entity1 , baseline mean    standard deviation average @entity158 score was 6.5    1.3, which decreased to 2.5    2.4 (P < 0.0001) at end of treatment. Similarly, least, worst, and current @entity158 scores were also reduced (P < 0.0001). Sixty-three percent of @entity1 achieved >=  50% @entity158 reduction from baseline. At the end of treatment, most @entity1 (88%) were satisfied or very satisfied with DETP. For 85% of @entity1 , investigators also reported being satisfied or very satisfied with DETP. Most @entity1 (87%) and investigators (88%, rating the @entity1 's response) rated global @entity158 relief as moderate to complete. Fifteen @entity1 experienced a total of 19 adverse events (AEs), 17 of which were mild to moderate, and 2 of which were severe. Three AEs were treatment related ( @entity1910 , @entity390 , and @entity591 ); 1 @entity1 had a serious AE (noncardiac @entity662 ) considered unrelated to DETP. CONCLUSION: In this exploratory study, @entity1 experienced well-tolerated relief for @entity615 , with >=  85% of @entity1 and their investigators expressing satisfaction with DETP treatment.

Effectiveness and safety of XXXX topical patch 1.3% for the treatment of @entity615 : an open-label, uncontrolled study.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity662 :: ('MESH:D002637', 'Disease') :: ['chest pain'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['application site rash'] @entity591 :: ('MESH:D013610', 'Disease') :: ['tachycardia'] @entity6475 :: ('MESH:D013180', 'Disease') :: ['sprains'] @entity615 :: ('MESH:D001416', 'Disease') :: ['acute pain due to back strain'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity17338 :: ('MESH:C064142', 'Chemical') :: ['diclofenac epolamine'] @entity12761 :: ('MESH:D059787', 'Disease') :: ['acute pain']
@entity17338 :: (MESH:C064142,Chemical) :: ['diclofenac epolamine']
