Inflammopharmacology

, Volume 15, Issue 1, pp 18–21

Are gastroprotective drugs useful for gastric ulcer healing: Re-evaluation using current ICH E9 guidelines

  • K. Higuchi
  • T. Watanabe
  • T. Tanigawa
  • M. Shiba
  • K. Tominaga
  • Y. Fujiwara
  • N. Oshitani
  • T. Arakawa
Research Article

DOI: 10.1007/s10787-006-0300-y

Cite this article as:
Higuchi, K., Watanabe, T., Tanigawa, T. et al. Inflammopharmacol (2007) 15: 18. doi:10.1007/s10787-006-0300-y

Abstract.

Most of the gastroprotective drugs which had been marketed in Japan were considered to have insufficient rationale for use as ulcer treatments. Such drugs may have a crucial role in maintaining mucosal integrity by the mechanisms other than inhibition of acid secretion. We re-evaluated the effect of gastroprotective drugs on gastric ulcer healing using current ICH E9 guidelines. We collected reports of pivotal trials on healing rate of gastric ulcer with 9 kinds of gastroprotective drugs submitted in New Drug Applications. In the comparative trial of cetraxate vs. placebo, the healing rate of gastric ulcer at 8-week endoscopy in the cetraxate was significantly higher than that in the placebo groups (88.6 % and 62.2 %, p = 0.0062). Non-inferiority to cetraxate was confirmed for 8 kinds of gastroprotective drugs. In conclusion, the superiority of cetraxate over placebo and non-inferiority to cetraxate for 7 drugs was established in the respect of effect on ulcer healing.

Keywords.

Gastric ulcerGastroprotective drugUlcer healing

Copyright information

© Birkhäuser Verlag, Basel 2007

Authors and Affiliations

  • K. Higuchi
    • 1
  • T. Watanabe
    • 1
  • T. Tanigawa
    • 1
  • M. Shiba
    • 1
  • K. Tominaga
    • 1
  • Y. Fujiwara
    • 1
  • N. Oshitani
    • 1
  • T. Arakawa
    • 1
  1. 1.Department of GastroenterologyOsaka City University Graduate School of MedicineOsakaJapan