Drugs

, Volume 35, Supplement 3, pp 76–81 | Cite as

Effects of Roxatidine Acetate on 24-Hour Gastric Acidity

Early Evening Versus Bedtime Administration in Healthy Subjects
  • P. Hemery
  • P. Congard
  • J.-P. Galmiche
  • S. Bonfils
Clinical Pharmacology of Roxatidine Acetate

Summary

The gastric antisecretory activity of roxatidine acetate was studied on 24-hour intragastric pH in 12 healthy male volunteers. The study was randomised, double-blind and double-dummy where either roxatidine acetate 150mg as a slow release granulated formulation or placebo were administered at 7.30pm or 10pm. Roxatidine acetate 150mg produced a significant decrease in the number of hours during which gastric acidity ranged between pH 1.5 and 4.0 which was consistent with the pharmacokinetic profile of the drug. There was no significant difference between the median intragastric pH values for early evening and bedtime administration of roxatidine acetate. The present data confirm that roxatidine acetate 150mg inhibits gastric acid secretion but while a single evening dose is effective in controlling intragastric pH the results suggest there is no clear advantage in an early evening dose compared with a bedtime dose.

Keywords

Duodenal Ulcer Ranitidine Roxatidine Roxatidine Acetate Antisecretory Drug 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Bonfils S. Représentation et analyse des résultats d’une pHmétrie gastrique de 24 heures. Gastroentérologie Clinique et Biologique 6: 944–945, 1982Google Scholar
  2. Dammann HG, Walter TA, Jenzewski H, Muller P, Simon B. H2-receptor antagonists: appropriate dosage regimens based on 24-hour intragastric H+activity profiles. In Bianchi-Porro & Bardhan (Eds) Topics in peptic ulcer disease, pp 19–27, Cortina International, Verona, 1987Google Scholar
  3. Fimmel CJ, Etienne A, Cilluffo T, Ritter C, Gasser T, et al. Long-term ambulatory gastric pH monitoring: validation of a new method and effect of H2-antagonists. Gastroenterology 88: 1842–1851, 1985PubMedGoogle Scholar
  4. Galmiche JP, Tranvouez JL, Denis P, N’Djitoyap C, Guillard JF, et al. L’enregistrement nocturne du pH gastrique permet-il de prévoir la réponse thérapeutique des ulcères duodénaux sévères traités par la ranitidine? Gastroentérologie Clinique et Biologique 9: 583–589, 1985PubMedGoogle Scholar
  5. Galmiche JP, Vallot T, Mayeur S, Arsène D, Ducrotte P, et al. Effet de la ranitidine sur le pH gastrique chez le sujet sain: intérêt de l’enregistrement continu sur 24 heures pour le choix du fractionnement optimal d’une dose thérapeutique. Gastroentérologie Clinique et Biologique 6: 352–359, 1982PubMedGoogle Scholar
  6. Gledhill T, Buck M, Paul A. Cimetidine or vagotomy? Comparison of the effects of proximal gastric vagotomy, cimetidine, and placebo on nocturnal intragastric acidity and acid secretion in patients with cimetidine resistant duodenal ulcer. British Journal of Surgery 70: 704–706, 1983PubMedCrossRefGoogle Scholar
  7. Hemery P, Galmiche JP, Rozé C, Isal JP, Bruley de Varannes S, et al. Low dose omeprazole effects on gastric acid secretion in normal man. Gastroentérologie Clinique et Biologique 11: 148–153, 1987PubMedGoogle Scholar
  8. Howden CW, Jones DB, Burget DW, Hunt RH. Comparison of the effects of gastric anti-secretory agents in healthy volunteers and patients with duodenal ulcer. Gut 27: 1058–1061, 1986PubMedCrossRefGoogle Scholar
  9. Labs RA. Interaction of roxatidine acetate with antacids, food and other drugs. Drugs 35 (Suppl. 3): 82–89, 1988PubMedCrossRefGoogle Scholar
  10. Merki H, Witzel L, Harre K, Scheurle E, Bauerfeind P, et al. Circadian pattern of intragastric acidity in duodenal ulcer (DU) patients: a comparison with healthy controls (HC). Gastroenterology 90: 1549(abstr.), 1986Google Scholar
  11. Merki H, Witzel L, Harre K, Scheurle E, Neumann J, et al. Single dose treatment with H2-receptor antagonists: is bedtime administration too late? Gut 28: 451–454, 1987PubMedCrossRefGoogle Scholar
  12. Merki H, Witzel L, Hüttemann W, Ansari A, Paniel M, et al. Single dose (sd) treatment with H2-receptor antagonists: a comparison of an early evening dose vsbedtime administration of ranitidine (R) in the treatment of duodenal ulcers (DU). Gastroenterology 90: 1550 (abstr.), 1986Google Scholar
  13. Merki H, Witzel L, Kaufmann D, Kempf M, Neumann J, et al. The effects of roxatidine acetate on 24-hour intragastric acidity: investigations in healthy volunteers and comparison with raniditine and placebo. Drugs 35 (Suppl. 3): 69–75, 1988PubMedCrossRefGoogle Scholar

Copyright information

© ADIS Press Limited 1988

Authors and Affiliations

  • P. Hemery
    • 1
  • P. Congard
    • 2
  • J.-P. Galmiche
    • 1
  • S. Bonfils
    • 2
  1. 1.Clinique des Maladies de l’Appareil DigestifCHU NordNantes
  2. 2.Clinique des Maladies de l’Appareil DigestifHôpital BichatParisFrance

Personalised recommendations