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 Clinical Trial
— RefreshOfficial title:
Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational Study
| Verified date | September 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Observational |
Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study.
| Status | Completed |
| Enrollment | 855 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Daejeon | |
| Korea, Republic of | Research Site | Gangneung | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Gwangju | |
| Korea, Republic of | Research Site | Incheon | |
| Korea, Republic of | Research Site | Jeonju-si | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of recurrence after treatment with PPI in patients with GERD | 12month | No | |
| Primary | Response rate to the treatment with PPI in patients with GERD | 12month | No | |
| Secondary | Baseline characteristics related to the recurrence of GERD | 12month | No | |
| Secondary | Rate of complete resolution in each group of patients with ERD or NERD | 12month | No | |
| Secondary | Rate of recurrence in each group of patients with ERD or NERD | 12month | No | |
| Secondary | Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD | 12month | No |