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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01018160
First received: November 19, 2009
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: Rabeprazole Sodium
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Practice and Patient Compliance on the PPI(Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea: A Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • GERD Symptom improvement [ Time Frame: 4 weeks, 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Actual administrating dosage of PPI during the GERD treatment period [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Visit interval during the GERD treatment [ Time Frame: 16 week ] [ Designated as safety issue: No ]
  • Duration of GERD initial therapy [ Time Frame: 16 week ] [ Designated as safety issue: No ]
  • Ratio of GERD patients who received endoscopy [ Time Frame: 16 week ] [ Designated as safety issue: No ]
  • Ratio of GERD patients who received PH Monitoring Test [ Time Frame: 16 week ] [ Designated as safety issue: No ]

Enrollment: 1197
Study Start Date: June 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Drug: Rabeprazole Sodium
10mg - 20mg tablet once or twice daily for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Among the patients who visit the department of gastroenterology with gastroesophageal reflux disease and who need rabeprazole treatment according to the doctor's discretion

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018160

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01018160     History of Changes
Other Study ID Numbers: CR015436
Study First Received: November 19, 2009
Last Updated: April 24, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Rabeprazole sodium
Gastroesophageal Reflux
GERD
Observational

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014