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  • [Topical gel formulation of ibuprofen in the treatment of acute and chronic joint and soft tissue pain. Results of a non-interventional observational trial].

[Topical gel formulation of ibuprofen in the treatment of acute and chronic joint and soft tissue pain. Results of a non-interventional observational trial].

MMW Fortschritte der Medizin (2013-05-18)
M Petersen-Braun, T Wegener
ABSTRACT

Pain, inflammation or swelling of soft tissues orjoints is often treated with oral or topical formulation of lbuprofen. Thetherapeutic effect of a topical gel formulation of Ibuprofen (doc Ibuprofen Schmerzgel) was investigated in an observational trial. A total of 170 patients suffering either from pain, inflammation or swelling of soft tissues or joints or having experienced a blunt trauma were enrolled into this study. Physicians and patients evaluated typical symptoms at study entry and after 1 week at the final visit. Further, the patients were asked and instructed to monitor their symptoms in a daily diary over this week. Patientssufferingfromacute trauma (group A (symptoms existent up to 48 hours) as well as patients with chronic symptoms (group B) experienced a fast and prominent improvement of symptoms. In group A total reduction of all symptoms after one week was recorded to amount to considerably more than 80%, in group B a reduction of more than 50% compared to the initial scores could be seen. Evaluation done by physicians and patients were extremely concordant with regard to timecourse and final outcome of the treatment. After first use on day one group A noted a reduction of pain symptoms after approximately 25 minutes, while in group B a considerable relief of pain was reported after approximately 37 minutes. During this one-week treatment period no adverse-effects were reported.Tolerability and applicability were classified as good to excellent. The results of this study confirm findings from existing clinical trials data. In acute traumata a faster symptom relief is found, in chronic conditions the product leads to symptom reduction in case seven where pretreatment has shown insufficient results. Thus this topical treatment provides a treatment option either alone or in combination with orally taken NSAIDS.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Ibuprofen, meets USP testing specifications
Sigma-Aldrich
Ibuprofen, ≥98% (GC)
Supelco
Ibuprofen sodium salt, ≥98% (GC)
Supelco
Ibuprofen, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Ibuprofen
Ibuprofen for peak identification, European Pharmacopoeia (EP) Reference Standard
Ibuprofen, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
(S)-(+)-Ibuprofen, ReagentPlus®, 99%
Supelco
Ibuprofen solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®