Journal of Pharmacology and Pharmacotherapeutics

RESEARCH PAPER
Year
: 2012  |  Volume : 3  |  Issue : 4  |  Page : 320--324

Comparison of the effectiveness and safety of cefpodoxime and ciprofloxacin in acute exacerbation of chronic suppurative otitis media: A randomized, open-labeled, phase IV clinical trial


Arijit Ghosh1, Utpal Jana2, Ajoy Khaowas2, Saumik Das2, Ananya Mandal1, Nina Das1 
1 Department of Pharmacology, Nilratan Sircar Medical College, Kolkata, India
2 Department of E.N.T., Nilratan Sircar Medical College, Kolkata, India

Correspondence Address:
Arijit Ghosh
Department of Pharmacology, Nilratan Sircar Medical College, Kolkata
India

Objective : To compare the effectiveness and safety of cefpodoxime and ciprofloxacin for the treatment of mild to moderate cases of acute exacerbation of chronic suppurative otitis media (AECSOM). Materials and Methods : Adult patients diagnosed with AECSOM were screened and patients fulfilling the inclusion criteria were randomized to receive either cefpodoxime 200 mg twice daily or ciprofloxacin 500 mg twice daily orally for 7 days. The primary outcome of this randomized, open-labeled, phase IV clinical trial (Registration Number - CTRI/2011/10/002079) was clinical success rate at day 14 visit and the secondary outcome was incidence of adverse events (AEs). Forty-six patients were enrolled: 23 in the cefpodoxime group and 23 in the ciprofloxacin group. Results : The clinical success rates were 95.6% in the cefpodoxime group versus 90.9% in the ciprofloxacin group. These rates are comparable, but no statistically significant difference was observed between the groups. Few mild and self-limiting AEs were observed and the tolerability of both the drugs was also good. Conclusion : The results of this randomized, open-labeled phase IV clinical trial showed that a 7-day course of cefpodoxime is therapeutically comparable to ciprofloxacin in terms of both clinical effectiveness and safety for the treatment of patients with AECSOM.


How to cite this article:
Ghosh A, Jana U, Khaowas A, Das S, Mandal A, Das N. Comparison of the effectiveness and safety of cefpodoxime and ciprofloxacin in acute exacerbation of chronic suppurative otitis media: A randomized, open-labeled, phase IV clinical trial.J Pharmacol Pharmacother 2012;3:320-324


How to cite this URL:
Ghosh A, Jana U, Khaowas A, Das S, Mandal A, Das N. Comparison of the effectiveness and safety of cefpodoxime and ciprofloxacin in acute exacerbation of chronic suppurative otitis media: A randomized, open-labeled, phase IV clinical trial. J Pharmacol Pharmacother [serial online] 2012 [cited 2020 Aug 5 ];3:320-324
Available from: http://www.jpharmacol.com/article.asp?issn=0976-500X;year=2012;volume=3;issue=4;spage=320;epage=324;aulast=Ghosh;type=0