Safety of Rabeprazole in Patients Under Multiple Treatments

Gastroesophageal Reflux Clinical Trial

Official title:

Safety of Rabeprazole in Patients Under Multiple Treatments

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00511745
• Other study ID #: CR009238
• Status: Terminated
• Phase: N/A
• First received: August 2, 2007
• Last updated: May 18, 2011
• Est. completion date: November 2002

Study information

• Verified date: April 2010
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2157
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant or lactating patients

• Other severe concomitant pathologies

• History or drug or alcohol abuse

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Ulcer
• Gastroesophageal Reflux
• Stomach Ulcer

Intervention

Drug:
• Rabeprazol
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of rabeprazole 20mg/day in polymedicated patients		2 or 8 weeks, as per investigator criteria	No
Secondary	No secondary outcome measures			No

External Links

•   Safety of rabeprazole in patients under multiple treatments.