Official Title: “Safety of Rabeprazole in Patients Under Multiple Treatments.”

The purpose of this study is to evaluate the safety of Rabeprazole 20mg/day in polymedicated patient and to examine the necessity of adjusted dosage in both therapies (Rabeprazole and concomitant drug). Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPIs block ATP-ase H+/K+ in gastric parietals cells. It has been described that inhibition of acid secretion has produced the recovery of the Gastroesophageal pathology in a high percentage of the patients resistant to conventional drugs. In this context, the objective of the study was to evaluate the safety of Rabeprazole as a concomitant treatment and examine the clinical practice the interaction with drugs whose absorption has gastric pH dependence.

Study Type: Observational

Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Rabeprazole is a new proton pump inhibitor (PPI) with potent anti-secretion action and dose-dependence activity. Rabeprazole is rapidly eliminated by hepatic metabolism and renal clearance. Rabeprazole is transformed in four metabolites: tioeter-, sulfone-, dismetil- and dismetil-tioeter-metabolites following a metabolic pathway that implicates an non-enzimatic via and CYP2C19 and CYP3A4. Sodium Rabeprazole as other PPIs is metabolizated by the hepatic drug metabolic system of the cytochrome P450 (CYP3A4 and CYP2C19). In previous studies in healthy volunteers interactions between Sodium Rabeprazole and drugs such as Warfarine, Theophiline, Diazepam and Phenytoin have not been found. In vitro studies in human hepatic microsomes have been described that Rabeprazole inhibits ciclosporine similar to other PPIs.

In this context, the objective of the study is to evaluate the safety of Rabeprazole as concomitant treatment and examine the clinical practice of the interaction with drugs whose absorption has a gastric pH dependence. This is an observational, multicenter, open and prospective study. It is expected to enroll 500 patients receiving Rabeprazole and a concomitant drug (one or more). All data collected will be prospective and will include the following: demographic data, adherence and compliance with treatment, lifestyle (smoking and alcohol consumption) and dose of Rabeprazole. Safety analysis will be based on adverse events.

For patients with Duodenal or Gastric Ulcer: rabeprazole 20mg per day, orally, for 4-6 weeks; For patients with Erosive or Ulcerate Gastroesophagic Reflux: rabeprazole orally 20mg/ per day, 4-8 weeks; For patients with Gastroesophagic Reflux requiring prolonged treatment:

rabeprazole orally 10 or 20 mg per day; For patients with H. Pylori: rabeprazole orally 20mg twice per day , Claritromicine orally 500mg 2 times per day and Amoxiciline 1gram orally twice daily for one week.

Inclusion Criteria:

• Patients receiving Rabeprazole and a concomitant drug (one or more) such a NSAIs, benzodiazepines or corticoids

Exclusion Criteria:

• Pregnant patients or lactating
• Other severe concomitant pathologies
• Drugs or alcohol abuse

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen-Cilag S.A., (formerly Janssen Sp)

Overall Clinical Trial Officials and Contacts

Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Study Director Janssen-Cilag S.A., (formerly Janssen Sp)  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00511745

Study ID Number: CR009238

ClinicalTrials.gov Identifier: NCT00511745

Health Authority: Spain: Spanish Drug Agency

Safety of rabeprazole in patients under multiple treatments.