A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease (GERD)
The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in routine primary health care.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Non Interventional Post Authorization Safety Study (PASS) On The Rabeprazole's Administration To Adults With Gastro-Oesophageal Reflux Disease (GORD)|
- Incidence of adverse events throughout treatment (8 weeks) and follow up (12 months)
- Severity of symptoms at baseline and specified intervals during treatment and follow up, rated from "no problem" to "very severe problem"; physical examination and laboratory tests at end of treatment and after 4 months
|Study Start Date:||March 2003|
|Study Completion Date:||November 2005|
Gastroesophageal reflux can result in mild to severe symptoms in some persons. Heartburn, a burning sensation or discomfort rising behind the breastbone, is a common symptom. Gastroesophageal reflux disease (GERD) can be described as a condition with clearly identified clinical symptoms or the change in tissue structure that results from the reflux of contents from the stomach or small intestine into the esophagus. This is a study to confirm the safety and effectiveness of rabeprazole in the treatment of patients with GERD in routine primary health care. The study has two phases. Patients will receive treatment with rabeprazole tablets once daily for 8 weeks. In the second phase, patients will be monitored by their physician for a follow up period to end of study (12 months). Safety assessments include the incidence of adverse events throughout the treatment and follow up phases, and physical examination and laboratory tests at end of treatment and after 4 months. Assessments of effectiveness include the degree of relief of symptoms at beginning and end of treatment and at specific intervals during follow up. The study hypothesis is that rabeprazole is well-tolerated with long term treatment of patients with GERD in routine primary health care. Rabeprazole tablet (20 milligrams[mg]) once daily in the morning for 8 weeks. Dose may be increased to 2 tablets daily (40 mg maximum) at investigator's discretion.