Clinical Drug Investigation

, Volume 29, Issue 4, pp 265–274 | Cite as

Generic versus Non-Generic Formulation of Extended-Release Clarithromycin in Patients with Community-Acquired Respiratory Tract Infections

A Prospective, Randomized, Comparative, Investigator-Blind, Multicentre Study
  • J. R. Snyman
  • H. S. Schoeman
  • M. P. Grobusch
  • M. Henning
  • W. Rabie
  • M. Hira
  • K. Parshotam
  • Y. Mithal
  • S. Singh
  • Z. Ramdas
Original Research Article

Abstract

Background and objective: There is a general concern about the use of multi-source (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modified-release formulations of clarithromycin (i.e. the originator Klacid XL® and the generic Klarithran MR®) were compared in patients with acute community-acquired respiratory tract infections.

Methods: Patients presenting with tonsillopharyngitis, sinusitis or pneumonia were randomized to receive either of the test drugs provided they clinically qualified for empirical clarithromycin treatment. The study endpoints were clinical and bacteriological cure rates, tolerability and safety. The study was designed to test for non-inferiority with regard to cure rates.

Results: The main outcome of this study was that both agents had similar clinical (non-inferior) and bacteriological cure rates and demonstrated no difference in tolerability in patients. The study also demonstrated the clinical efficacy of clarithromycin when used as empirical treatment in patients with respiratory tract infections in community practice (i.e. 95% clinical cure rate).

Conclusion: The clarithromycin extended-release multisource product (Klarithran MR®) does not differ significantly from the originator (Klacid XL®) and the clinical cure rate of the generic formulation is non-inferior to that of the originator. The two formulations are tolerated similarly.

Keywords

Clarithromycin Sinusitis Clinical Cure Rate Moraxella Catarrhalis Bacteriological Cure 

Notes

Acknowledgements

This study was sponsored by Ranbaxy Laboratories (SA) (Pty) Ltd.

Prof. Snyman, Prof. Grobusch, Dr Henning, Dr Rabie, Dr Hira, Dr Parshotam and Dr Mithal act as clinical research consultants to pharmaceutical companies, including Ranbaxy, in South Africa. Prof. Schoeman acts as a biostatistical consultant for the entire pharmaceutical industry in South Africa. Dr Singh and Mr Ramdas are employees of Ranbaxy (SA) (Pty) Ltd.

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Copyright information

© Adis Data Information BV 2009

Authors and Affiliations

  • J. R. Snyman
    • 1
  • H. S. Schoeman
    • 2
  • M. P. Grobusch
    • 3
  • M. Henning
    • 4
  • W. Rabie
    • 5
  • M. Hira
    • 6
  • K. Parshotam
    • 7
  • Y. Mithal
    • 8
  • S. Singh
    • 9
  • Z. Ramdas
    • 9
  1. 1.Department of Pharmacology, School of MedicineUniversity of PretoriaPretoriaSouth Africa
  2. 2.Private Consultant BiostatisticianPretoriaSouth Africa
  3. 3.Infectious Disease Unit, Department of Clinical Microbiology and Infectious Diseases, NHLS and School of Pathology, Faculty of Health SciencesUniversity of the WitwatersrandJohannesburgSouth Africa
  4. 4.Vermaak and Partners PathologistsCenturionSouth Africa
  5. 5.Department of Family MedicineUniversity of the Free StateBloemfonteinSouth Africa
  6. 6.Tshepong Health CentreJohannesburgSouth Africa
  7. 7.Private PracticeRoodepoortSouth Africa
  8. 8.Private PracticeJohannesburgSouth Africa
  9. 9.Ranbaxy (SA) (Pty) LtdCenturionSouth Africa

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