Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 19, 2009
April 24, 2014
June 2008
February 2009   (final data collection date for primary outcome measure)
GERD Symptom improvement [ Time Frame: 4 weeks, 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018160 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Practice and Patient Compliance on the PPI (Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea
Practice and Patient Compliance on the PPI(Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea: A Prospective Observational Study

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Gastroesophageal Reflux
Drug: Rabeprazole Sodium
10mg - 20mg tablet once or twice daily for 12 weeks
001
Intervention: Drug: Rabeprazole Sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1197
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01018160
CR015436
No
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
Janssen Korea, Ltd., Korea
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP