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Completed

NCT Number: NCT02606851

Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. The overall responder rate

    Time frame: After 4 weeks of Proton Pump Inhibitor empirical treatment

    The overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment. Responder is defined as heartburn/regurgitation frequency ≤1 days during 7 days before evaluation visit, assessed using Gerd Q questionnaire at each post-baseline visit.

Secondary outcomes

  1. The overall responder rate

    Time frame: After 2 weeks of Proton Pump Inhibitor empirical treatment

    The overall responder rate after 2 weeks of Proton Pump Inhibitor empirical treatment

  2. The proportion of patients in each Gerd Q cut-off range at each visit

    Time frame: At each visit (baseline, 2 weeks and 4 weeks)

    The proportion of patients in each Gerd Q cut-off range at each visit (Gerd Q range: ≤2; 3-7; 8-10; 11-18)

  3. The responder rate of different Proton Pump Inhibitor empirical treatment

    Time frame: After 2 and 4 weeks of different PPIs empirical treatment

    The responder rate respectively after 2 and 4 weeks of different Proton Pump Inhibitor empirical treatment

  4. The median time to response overall and for different Proton Pump Inhibitor, respectively

    Time frame: During 4 weeks of whole study

    The median time to response (heartburn/regurgitation frequency ≤1 days during last 7 days assessed using patient's diary card) overall and for different Proton Pump Inhibitor, respectively

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
Nov 17, 2017

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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