Safety of Rabeprazole in Patients Under Multiple Treatments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2157 participants

Study Classification

OBSERVATIONAL

Study Completion Date

2002-11-30

Brief Summary

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The purpose of this study is to evaluate the safety of rabeprazole 20mg/day in polymedicated patients 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. PPI's 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 is 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.

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Detailed Description

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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. In previous studies in healthy volunteers, interactions between sodium rabeprazole and drugs such as warfarin, theophyline, diazepam and phenytoin have not been found. 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. Observational Study: 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 , Clarithromycin orally 500mg 2 times per day and Amoxicillin 1gram orally twice daily for 1 week.

Conditions

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Gastroesophageal Reflux Gastric Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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001

Rabeprazol

Intervention Type DRUG

As prescribed

Interventions

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Rabeprazol

As prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients receiving Rabeprazole and a concomitant drug (one or more) such a non-steroidal anti-inflammatory drugs (NSAID), benzodiazepines or corticoids