Safety of Rabeprazole in Patients Under Multiple Treatments.
Information source: Janssen-Cilag S.A., (formerly Janssen Sp)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Ulcer; Gastroesophageal Reflux
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Janssen-Cilag S.A., (formerly Janssen Sp) Official(s) and/or principal investigator(s):
Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study Director, Affiliation: Janssen-Cilag S.A., (formerly Janssen Sp)
Summary
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.
Clinical Details
Official title: Safety of Rabeprazole in Patients Under Multiple Treatments.
Study design: Natural History, Longitudinal, Defined Population, Prospective Study
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Safety of rabeprazole in patients under multiple treatments.
Ending date: November 2002
Last updated: August 6, 2007
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