Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511745
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2007-08-02
Brief Title:
Safety of Rabeprazole in Patients Under Multiple Treatments
Sponsor:
Janssen-Cilag SA
Organization:
Janssen-Cilag SA
Study Overview
Official Title:
Safety of Rabeprazole in Patients Under Multiple Treatments
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the achievement of minimum required sample size and new changes in local regulations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of rabeprazole 20mgday 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 PPIs block ATP-ase HK 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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None