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Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study - PRIME study

To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician's routine...

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Bibliographic Details
Published in:Journal of pain research 2017-01, Vol.10, p.1273-1278
Main Authors: Shah, Kshitij, Chaudhari, Omvijay B, Gupta, Palash, Chaudhuri, R Hom, Kamilya, Ranjan, Kulkarni, Shreedhar S, Subbaiah, S, Sorathia, Zubair H, Billa, Gauri
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Language:English
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Summary:To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician's routine clinical practice. In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18-60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (
ISSN:1178-7090
1178-7090
DOI:10.2147/JPR.S123772