Safety of Rabeprazole in Patients Under Multiple Treatments

Status Terminated

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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00511745
Study type	Observational
Source	Janssen-Cilag, S.A.
Contact
Status	Terminated
Phase	N/A
Completion date	November 2002

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05561179` - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease	N/A
Withdrawn	`NCT02213887` - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications	Phase 4
Completed	`NCT01946971` - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)	Phase 1/Phase 2
Recruiting	`NCT01825473` - Study of Erythromycin in GER-Associated Apnea of the Newborn	N/A
Completed	`NCT00614536` - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period	Phase 4
Completed	`NCT00284908` - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers	Phase 1
Completed	`NCT00365300` - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)	Phase 3
Completed	`NCT00373997` - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux	Phase 4
Completed	`NCT00291746` - Validation of RDQ Questionnaire	Phase 4
Completed	`NCT01167543` - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease	N/A
Completed	`NCT00567021` - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms	N/A
Completed	`NCT00141960` - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease	Phase 2/Phase 3
Completed	`NCT00215787` - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease	N/A
Completed	`NCT00226044` - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.	Phase 3
Completed	`NCT01048840` - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Completed	`NCT00181805` - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Terminated	`NCT01281553` - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease	Phase 4
Completed	`NCT05486169` - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy	N/A
Completed	`NCT04034017` - Gastroesophageal Reflux Disease Among College Students
Terminated	`NCT03226054` - Determining Risk Factors for Successful PPI Weaning	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.