Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216489
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
2005-09-13
Brief Title:
A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease GERD
Sponsor:
Janssen Cilag Pharmaceutica SACI Greece
Organization:
Janssen Cilag Pharmaceutica SACI Greece
Study Overview
Official Title:
A Non Interventional Post Authorization Safety Study PASS On The Rabeprazoles Administration To Adults With Gastro-Oesophageal Reflux Disease GORD
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 milligramsmg once daily in the morning for 8 weeks Dose may be increased to 2 tablets daily 40 mg maximum at investigators discretion
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