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Completed

NCT Number: NCT01018160

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RABEPRAZOLE SODIUM

Drug

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

Primary outcomes

  1. GERD Symptom improvement

    Time frame: 4 weeks, 16 weeks

Secondary outcomes

  1. Actual administrating dosage of PPI during the GERD treatment period

    Time frame: 16 weeks

  2. Visit interval during the GERD treatment

    Time frame: 16 week

  3. Duration of GERD initial therapy

    Time frame: 16 week

  4. Ratio of GERD patients who received endoscopy

    Time frame: 16 week

  5. Ratio of GERD patients who received PH Monitoring Test

    Time frame: 16 week

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 23, 2009
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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