Practice and Patient Compliance on the PPI (Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea
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| First Received Date ICMJE | November 19, 2009 | ||||
| Last Updated Date | April 26, 2010 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
GERD Symptom improvement [ Time Frame: 4 weeks, 16 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01018160 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Practice and Patient Compliance on the PPI (Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea | ||||
| Official Title ICMJE | Practice and Patient Compliance on the PPI(Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea: A Prospective Observational Study | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 |
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| Condition ICMJE | Gastroesophageal Reflux | ||||
| Intervention ICMJE | Drug: Rabeprazole Sodium
10mg - 20mg tablet once or twice daily for 12 weeks |
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| Study Group/Cohort (s) | 001
Intervention: Drug: Rabeprazole Sodium |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1197 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01018160 | ||||
| Other Study ID Numbers ICMJE | CR015436 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Clinical Research Director, Janssen Korea, Ltd., Korea | ||||
| Study Sponsor ICMJE | Janssen Korea, Ltd., Korea | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Janssen Korea, Ltd., Korea | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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