Clinical trial NCT01378338: Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational
Official title: Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-06-22
Enrollment: 855
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with typical reflux symptoms (heartburn or regurgitation) undergone upper endoscopy

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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of recurrence after treatment with PPI in patients with GERD
timeFrame: 12month
measure: Response rate to the treatment with PPI in patients with GERD
timeFrame: 12month
Secondary outcomes:
measure: Baseline characteristics related to the recurrence of GERD
timeFrame: 12month
measure: Rate of complete resolution in each group of patients with ERD or NERD
timeFrame: 12month
measure: Rate of recurrence in each group of patients with ERD or NERD
timeFrame: 12month
measure: Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD
timeFrame: 12month
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gangneung
country: Korea, Republic of
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jeonju-si
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca Korea
name: HyeWon Koo
role: STUDY_DIRECTOR
References: