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Journal of Gastroenterology

, Volume 44, Issue 7, pp 697–707 | Cite as

Randomized, parallel, double-blind comparison of the ulcer-healing effects of ilaprazole and omeprazole in the treatment of gastric and duodenal ulcers

  • Khek Yu Ho
  • Arlene Kuan
  • Felix Zaño
  • Khean Lee Goh
  • Varocha Mahachai
  • Dong Yeon Kim
  • Hwan Min Yoon
Original Article—Alimentary Tract

Abstract

Purpose

Ilaprazole (IY-81149) is a new proton-pump inhibitor (PPI) not previously studied in human patients with ulcer disease. This study evaluated and compared it with a reference PPI, omeprazole, in the treatment of gastric and duodenal ulcers.

Methods

This was a double-blind, parallel, randomized study. Patients aged 18 years and above with at least one endoscopically confirmed active non-malignant gastric/duodenal ulcer were treated with 20 mg/day omeprazole or 5 mg/day or 10 mg/day ilaprazole for four weeks. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated using a graded score. Safety and tolerability were evaluated on basis of clinical assessments. Between-group differences were tested using ANOVA or ANCOVA, as appropriate. Statistical significance was assumed at a two-tailed p value of ≤0.05.

Results

Two hundred and twelve gastric ulcer patients (median age 53.3 years) and 306 duodenal ulcer patients (median age 49.7 years) were recruited; 71.8 and 85% of gastric and duodenal ulcer patients, respectively, completed the study. Ulcers were successfully healed in 64.29, 67.14, and 63.89% of gastric ulcer patients and 78.85, 83.65, and 78.57% of duodenal ulcer patients after treatment with 20 mg omeprazole, 5 mg ilaprazole, and 10 mg ilaprazole, respectively. Most patients (>90%) became asymptomatic after treatment. At the dosages administered, both drugs exhibited similar efficacy and a similar safety profile.

Conclusions

Ilaprazole is as tolerable, safe, and efficacious as omeprazole in the treatment of gastroduodenal ulcers, at a much lower dose (5 vs. 20 mg omeprazole).

Keywords

Ilaprazole Proton-pump inhibitor Gastroduodenal ulcer Acid suppression 

Notes

Acknowledgments

The authors wish to thank Dr Jennie Wong for her editorial assistance. These data were published in abstract form (Gut 2006; 55 (Suppl V): A79) and were presented orally at the 14th United European Gastroenterology Week, Berlin, 2006.

Conflict of interest statement

This study was sponsored by Ilyang Pharmaceutical Company, Limited, Seoul, South Korea. None of the authors has financial interest in the study.

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Copyright information

© Springer 2009

Authors and Affiliations

  • Khek Yu Ho
    • 1
    • 2
  • Arlene Kuan
    • 3
  • Felix Zaño
    • 4
  • Khean Lee Goh
    • 5
  • Varocha Mahachai
    • 6
  • Dong Yeon Kim
    • 7
  • Hwan Min Yoon
    • 7
  1. 1.Department of Medicine, Yong Loo Lin School of Medicine, National University HospitalNational University of SingaporeSingaporeSingapore
  2. 2.Department of Gastroenterology and HepatologyNational University HospitalSingaporeSingapore
  3. 3.Vicente Sotto Medical CenterCebuPhilippines
  4. 4.Philippine General HospitalManilaPhilippines
  5. 5.University Malaya Medical CentreKuala LumpurMalaysia
  6. 6.Chulalonkorn HospitalBangkokThailand
  7. 7.Ilyang Central Research InstituteYonginSouth Korea

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