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NCT Number: NCT01378338

Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational

Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study.

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Key information

Conditions

The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPI Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Both ERD or NERD patient who confirmed by EGD findings within 12 months prior to V1 and have a symptom with moderate or more, at least once per week within 1 week prior to V1 and Patients between age 20 and 80with typical reflux symptoms
  • Among the patient who have not taken PPI or H2 blocker within 4 weeks prior to V1, needs to be prescribed PPIs 4~8 weeks as a part of the routine clinical practice due to typical symptom
  • Patients who give the signed informed consent

Exclusion criteria

  • Patients with past history of gastrointestinal surgery
  • Patients with known malignancy or history of such diseases
  • Patients with moderate to severe general medical conditions like ischemic heart disease, chronic renal failure, congestive heart failure, COPD, liver cirrhosis, acute or chronic pancreatitis, or other medical conditions which the investigator considers

Treatment and study plan

Primary outcomes

  1. Rate of recurrence after treatment with PPI in patients with GERD

    Time frame: 12month

  2. Response rate to the treatment with PPI in patients with GERD

    Time frame: 12month

Secondary outcomes

  1. Baseline characteristics related to the recurrence of GERD

    Time frame: 12month

  2. Rate of complete resolution in each group of patients with ERD or NERD

    Time frame: 12month

  3. Rate of recurrence in each group of patients with ERD or NERD

    Time frame: 12month

  4. Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD

    Time frame: 12month

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational Study

Acronym: Refresh

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 22, 2011
Registry last updated
Oct 1, 2013

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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