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

Gastroesophageal Reflux Clinical Trial

Official title:

Practice and Patient Compliance on the PPI(Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018160
• Other study ID #: CR015436
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2009
• Last updated: April 24, 2014
• Start date: June 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1197
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Rabeprazole Sodium
10mg - 20mg tablet once or twice daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GERD Symptom improvement		4 weeks, 16 weeks	No
Secondary	Actual administrating dosage of PPI during the GERD treatment period		16 weeks	No
Secondary	Visit interval during the GERD treatment		16 week	No
Secondary	Duration of GERD initial therapy		16 week	No
Secondary	Ratio of GERD patients who received endoscopy		16 week	No
Secondary	Ratio of GERD patients who received PH Monitoring Test		16 week	No