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| Sponsor: | Janssen-Cilag S.A., (formerly Janssen Sp) |
|---|---|
| Information provided by: | Janssen-Cilag S.A., (formerly Janssen Sp) |
| ClinicalTrials.gov Identifier: | NCT00511745 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastroesophageal Reflux Gastric Ulcer |
Drug: Rabeprazol |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Safety of Rabeprazole in Patients Under Multiple Treatments |
| Enrollment: | 2157 |
| Study Completion Date: | November 2002 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 001 |
Drug: Rabeprazol
As prescribed
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients receiving rabeprazole and a concomitant drug (one or more) such a non-steroidal anti-inflammatory drugs (NSAID), benzodiazepines or corticoids
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Country Medical Director, Janssen-Cilag S.A., Spain |
| ClinicalTrials.gov Identifier: | NCT00511745 History of Changes |
| Other Study ID Numbers: | CR009238 |
| Study First Received: | August 2, 2007 |
| Last Updated: | May 18, 2011 |
| Health Authority: | Spain: Spanish Drug Agency |
|
Interactions Adjusted doses Duodenal Ulcer Gastric Ulcer |
Erosive or ulcerate Gastroesophageal Reflux Rabeprazole Gastroesophageal reflux |
|
Gastroesophageal Reflux Stomach Ulcer Ulcer Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Peptic Ulcer |
Stomach Diseases Pathologic Processes Rabeprazole Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |