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

NCT01018160 | Completed

• 1 other identifier: CR015436
• Study Type: observational
• Target: 1,197
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroesophageal Reflux

Keywords

Rabeprazole sodium; Gastroesophageal Reflux; GERD; Observational

Outcome Measures

Primary Outcomes (1)

• GERD Symptom improvement

  4 weeks, 16 weeks

Secondary Outcomes (5)

• Actual administrating dosage of PPI during the GERD treatment period

  16 weeks

• Visit interval during the GERD treatment

  16 week

• Duration of GERD initial therapy

  16 week

• Ratio of GERD patients who received endoscopy

  16 week

• Ratio of GERD patients who received PH Monitoring Test

  16 week

Study Arms (1)

001

Drug: Rabeprazole Sodium

Interventions

Rabeprazole Sodium DRUG

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

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: June 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 28, 2014

Record last verified: 2014-04