Safety of Rabeprazole in Patients Under Multiple Treatments

This study has been terminated.
(Due to the achievement of minimum required sample size and new changes in local regulations.)
Sponsor:
Information provided by:
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT00511745
First received: August 2, 2007
Last updated: May 18, 2011
Last verified: April 2010

August 2, 2007
May 18, 2011
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Safety of rabeprazole 20mg/day in polymedicated patients [ Time Frame: 2 or 8 weeks, as per investigator criteria ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00511745 on ClinicalTrials.gov Archive Site
No secondary outcome measures [ Designated as safety issue: No ]
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Safety of Rabeprazole in Patients Under Multiple Treatments
Safety of Rabeprazole in Patients Under Multiple Treatments

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Gastroesophageal Reflux
  • Gastric Ulcer
Drug: Rabeprazol
As prescribed
001
Intervention: Drug: Rabeprazol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2157
November 2002
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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

Exclusion Criteria:

  • Pregnant or lactating patients
  • Other severe concomitant pathologies
  • History or drug or alcohol abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00511745
CR009238
No
Country Medical Director, Janssen-Cilag S.A., Spain
Janssen-Cilag, S.A.
Not Provided
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
Janssen-Cilag, S.A.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP