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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01378338

Acronym

Refresh

Enrollment

855

Registered

2011-06-22

Start date

2012-06-30

Completion date

2013-09-30

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Keywords

GERD, Comparison between ERD and NERD, Rate of complete resolution, rate of recurrence, QOL, To investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI, 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

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of recurrence after treatment with PPI in patients with GERD	12month
Response rate to the treatment with PPI in patients with GERD	12month

Secondary

Measure	Time frame
Baseline characteristics related to the recurrence of GERD	12month
Rate of complete resolution in each group of patients with ERD or NERD	12month
Rate of recurrence in each group of patients with ERD or NERD	12month
Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD	12month

Countries

South Korea

Outcome results