Clinical trial NCT02606851: Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.
Official title: China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Typical Symptoms of GERD (GERD Q >= 8)
Keywords: Proton Pump Inhibitor, GERD, GERD Q
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population that will be included in the NIS are the consecutive outpatients between 18 and 65 years old with Gerd Q ≥ 8, who will not have endoscopy within 4 weeks while gastroenterologists already prescribe PPI as empirical treatment.

Brief summary: China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease

Detailed description: To estimate the overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment This will be a multicenter prospective observational study carried out in China. Investigator will collect data in a pre-specified Case Report Form from the outpatient. Informed consents will be needed. Investigator will provide patient diary card to each patient for them to note down the symptom frequency every day. Main data from each outpatient will include demographics, Gerd Q, symptom frequency and Proton Pump Inhibitor empirical treatment. Data from each outpatient will be collected on the screening day, 2 weeks and 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.
* Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.
* GerdQ≥8
* The subject will not have endoscopy within 4 weeks after enrolment.
* Ability to provide informed consent, adhere to the study visit schedule, and complete all study assessments and complete the patient diary by his/herself.

Exclusion Criteria:

* If participating in any interventional clinical trial.
* Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia, hematemesis, melena).
* Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive drug within 2 weeks before screening.
* The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics during the upcoming 4 weeks (study duration).
* Previous gastroesophageal surgery.
* Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.
* Peptic ulcer
* Diabetes
* Cerebral vascular disease
* Zollinger-Ellison syndrome
* Scleroderma
* Hiatus hernia women
* Pregnant or lactating women
* Any other subjects were not suitable to this study in the opinion of the investigator.

Primary outcomes:
measure: The overall responder rate
timeFrame: After 4 weeks of Proton Pump Inhibitor empirical treatment
Secondary outcomes:
measure: The overall responder rate
timeFrame: After 2 weeks of Proton Pump Inhibitor empirical treatment
measure: The proportion of patients in each Gerd Q cut-off range at each visit
timeFrame: At each visit (baseline, 2 weeks and 4 weeks)
measure: The responder rate of different Proton Pump Inhibitor empirical treatment
timeFrame: After 2 and 4 weeks of different PPIs empirical treatment
measure: The median time to response overall and for different Proton Pump Inhibitor, respectively
timeFrame: During 4 weeks of whole study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Benijin
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Xining
country: China
facility: Research Site
Study officials:
affiliation: Changhai Hospital
name: Duowu Zou, leading PI
role: PRINCIPAL_INVESTIGATOR
References: