The amount of rescue medication used, particularly in the menthol and placebo groups, may also have influenced the results. Based on the clinical estimation of the performance of diclofenac from previous data,16 the effect of the diclofenac/menthol gel was assumed to be 27.5% greater than that of placebo and to show a difference of about 1.7 (8.0 for the diclofenac/menthol formulation vs. 6.3 for placebo). In addition, the participants will evaluate treatment satisfaction, sensory features of the gel and provide a global assessment of the treatment by using a questionnaire. The safety and ITT populations both comprised 381 patients, and 360 completed the trial (Figure 1). It took 2 days to really notice significant pain reduction. PID on movement, calculated as PI at a given time 't' (after walking 5 steps on a flat surface) subtracted by the PI at baseline. ,{i:'table5-0300060517700322',type:'table-wrap',g:[{m:'10.1177_0300060517700322-table5.gif',l:'10.1177_0300060517700322-table5.jpeg',size:'274 KB'}]} This study failed to show a statistically significant difference in the efficacy of topical 1% diclofenac/3% menthol gel self-administered four times daily compared with placebo, 1% diclofenac gel, or 3% menthol gel in the treatment of pain related to ankle sprain. New login is not successful because the max limit of logins for this user account has been reached. The inclusion criteria were an ankle PI score of ≥5 on an 11-point NRS, at rest or during movement, and perimalleolar edema (submalleolar perimeter difference of ≥20 mm between the injured and uninjured ankles as assessed using the “figure-of-eight” method). Drug: 1% diclofenac sodium plus 3% menthol To be applied four times daily for 10 days. This study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain. The ITT population included 117 patients in the diclofenac/menthol group, 112 in the 1% diclofenac group, 77 in the 3% menthol group, and 75 in the placebo treatment group. Access to society journal content varies across our titles. The other secondary efficacy outcomes (Tables 3 and 4) did not reveal any meaningful advantages for 1% diclofenac/3% menthol over placebo or either active control. ,{i:'fig2-0300060517700322',type:'fig',g:[{m:'10.1177_0300060517700322-fig2.gif',l:'10.1177_0300060517700322-fig2.jpeg',size:'144 KB'}]} Comparison of diclofenac gel, ibuprofen gel, and ibuprofen gel with le... Kerkhoffs, GM, van den Bekerom, M, Elders, LA. ,{i:'table2-0300060517700322',type:'table-wrap',g:[{m:'10.1177_0300060517700322-table2.gif',l:'10.1177_0300060517700322-table2.jpeg',size:'115 KB'}]} Medical writing assistance was provided by Peloton Advantage, Parsippany, NJ and was funded by GlaxoSmithKline Consumer Healthcare. PI was measured on NRS scale from 0 (no pain) to 10 (extreme pain). They recorded pain intensity (PI) at baseline and then recorded PI and PR at 10 and 30 minutes; at 1, 4, 6, 12, 18, and 24 hours after the first dose; and then twice daily on days 2 through 10. Time of onset of cooling sensation measured by time when subjects reported to have a 'cooling effect as an enhancement of pain relief'. The possible range of TOTPAR for 0-6 hours was from 0 to 24, for 0-12 hours was from 0 to 48, for 0-24 hours was from 0 to 96, for 0-72 hours was from 0 to 288, for 24-72 hours was from 0 to 192 and for 0-168 hours was from 0 to 672. The patients were aged 16 to 65 years and had a unilateral grade I or II acute sprain of the lateral or medial ankle that had occurred within 24 hours of presentation to one of the clinic sites based on the patient’s self-report. Treatment-emergent adverse events in the safety population. ,{i:'table5-0300060517700322',type:'table-wrap',g:[{m:'10.1177_0300060517700322-table5.gif',l:'10.1177_0300060517700322-table5.jpeg',size:'274 KB'}]} AUC1–3 for pain intensity on movement with 1% diclofenac/3% menthol gel compared with 1% diclofenac gel, 3% menthol gel, and placebo gel in the intent-to-treat population, There were no statistically significant differences in the PRS between 1% diclofenac/3% menthol gel and placebo or either active control at any time point from 10 minutes to 72 hours after the first treatment application (Figure 2). Submitted for publication September 2010. �$�]�G�c(�V�@�X����$�,�Xf)����Ų��$>�\u4�eɥ0bى�4�e/��Q,���^�}�Al�D6�䜪$�$�� k")�I,KDb�\�؊QbLF,�1W�XNR�$�b��y+��!�&�k"exH6�LnH��&�,�O��#��*O!3��$�d�r���g/�����7��b���,�&����������q�v}��u~�oityw��]l7�:��z�=;˖��Q�9�u��P��Ls������v��!�#�#س�Dž�`Aԁz� A�)kPJ�����{����u�x�x�x�|���s�w�w�w�w�w����'Pʠԃ������j@�=�x;��!���1��X�فz� Z��y�f���nƺ�f�;�)�hg1Ύ���4�F�2�5#(��E�[ԹE�[�9�.uA�B]�b@#h��҈�2�J=�����S��]�.���j���U�TUVPU5EUuTaUC����S`մ*�j)��+�ؚ��ખG�We�����lYeYaVY�@��W�U6(ؖ�*�*�&Vz�A���8�⯲VXYVV�) There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac. Safety outcomes included frequency, severity, and the relationship between treatment and adverse events (AEs) and serious AEs. Lionberger, DR, Joussellin, E, Yanchick, J. Pain relief was assessed using a 5-point scale: 0 = no pain relief, 1 = a little or perceptible pain relief, 2 = meaningful pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. The patients were recruited by placing advertisements in pharmacies close to the study center and in sports facilities/clubs, as well as by providing information about the study directly to trainers to encourage referral. Galeotti, N, Di Cesare Mannelli, L, Mazzanti, G. Efficacy and safety of diclofenac sodium topical gel 1% applied four times daily in subjects with acute ankle sprain (NCT01272934). For more information view the SAGE Journals Article Sharing page. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. Contact us if you experience any difficulty logging in. ClinicalTrials.gov. The marked applicator strip contained two circles with an X marked in the center of each; the patients were instructed to squeeze the tube to dispense the gel into the center of each circle until the gel filled the circle completely, which provided a dose of approximately 4 g. Randomization numbers were assigned to eligible patients in ascending numerical order, with both patients and key staff blinded to the treatment allocation. Efficacy was evaluated in the intent-to-treat (ITT) population, which comprised patients who were randomized, received treatment, and provided at least one post-baseline efficacy assessment. Overall compliance was calculated as the mean of the individual patients’ compliance. They completed and recorded subsequent treatment applications and assessments using a paper diary card at home.

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