Practice and Patient Compliance on the PPI (Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea

NCT ID: NCT01018160

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1197 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-02-28

Brief Summary

The purpose of this study is to examine the treatment profile of approximately 1,000 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 1,000 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 investigator's 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 treatment.The 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.

Conditions

Gastroesophageal Reflux

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

001

Rabeprazole Sodium

Intervention Type: DRUG

10mg - 20mg tablet once or twice daily for 12 weeks

Interventions

Rabeprazole Sodium

10mg - 20mg tablet once or twice daily for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients complaining about heartburn or acid regurgitation, the typical GERD symptoms, more than once a week
• After a full explanation about the observational study, patients who fully understand it and sign a written consent form

Exclusion Criteria

• Patients who took rabeprazole sodium within the last four weeks
• Patients who are hypersensitive to the active ingredient of rabeprazole sodium or benzimidazole
• Patient with other digestive tract diseases other than GERD (gastrointestinal cancer, liver disease, pancreatic disease, peptic ulcer, inflammatory digestive tract diseases [in case of ulcer, however, scars from healed ulcer may be included])
• Patients with other severe accompanying diseases including renal impairment, cerebrovascular disease, cardiovascular disease and severe respiratory disease
• Patients who must constantly take Proton Pump Inhibitors other than rabeprazole sodium during study period
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd.

Other Identifiers

CR015436

Identifier Type: -

Identifier Source: org_study_id