Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01018160
Status:
COMPLETED
Last Update Posted:
2014-04-28
First Post:
2009-11-19
Brief Title:
Practice and Patient Compliance on the PPI Proton Pump Inhibitors Treatment of Gastroesophageal Reflux in South Korea
Sponsor:
Janssen Korea Ltd Korea
Organization:
Janssen Korea Ltd Korea
Study Overview
Official Title:
Practice and Patient Compliance on the PPIProton Pump Inhibitors Treatment of Gastroesophageal Reflux in South Korea A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2014-04
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 this study is to examine the treatment profile of approximately 1000 adult patients with gastroesophageal reflux who begin raberpazole sodium treatment for 4 months and assess patients adherence to the study drug
Detailed Description:
This study is a multicenter open-labeled prospective phase IV observational study for patients visiting the gastroenterology department The purpose of this study is to examine the treatment profile of approximately 1000 adult patients with gastroesophageal reflux GERD who begin raberpazole sodium treatment for 4 months and assess patients adherence to the study drug The primary objective is to examine the treatment profile of gastroesophageal reflux in the secondary or tertiary clinical center The secondary objective is to examine GERD patients adherence to the study drug rabeprazole sodium during the treatment period Of the patients who visit the study centers and complain about gastroesophageal reflux symptoms during the study period those who are deemed to need rabeprazole sodium administration at the investigators discretion will be considered for this study The main outcome measures are the patterns of gastroesophageal reflux management eg treatment duration of initial therapy etc and the compliance of proton pump inhibitor treatmentThe compliance data number of tablets taken will be calculated at the clinical visit by counting the number of dispensed tablets that are remaining Also investigators will observe the gastroesophageal reflux symptom free rate at the end of initial therapy gastrointestinal GI symptom relief and safety information at each visit Study period is up to 4 months During the study no standardized treatment is stipulated and patients may receive any treatment considered by their physicians Rabeprazole sodium 10 mg - 20 mg tablet once daily for 4months
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