Patients With Typical Symptoms of GERD (GERD Q >= 8)NCT02606851
Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.
An observational study of Patients With Typical Symptoms of GERD (GERD Q >= 8), run by AstraZeneca at 10 sites in China.
Trial summary
China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Typical Symptoms of GERD (GERD Q >= 8)
- How many people
- 1,000 participants
- Where
- 10 sitesChina
- Study dates
- 4 Dec 2015to 28 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Research Site
Beijing
Research Site
Benijin
Research Site
Changchun
Research Site
Chongqing
Research Site
Guangzhou
Research Site
Hangzhou
Research Site
Nanjing
Research Site
Shanghai
Research Site
Tianjin
Research Site
Xining
About this study
Official title: China Survey of 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
Read the 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.
- Keywords
- Proton Pump Inhibitor, GERD, GERD Q
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall responder rate
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.
Measured: After 4 weeks of Proton Pump Inhibitor empirical treatment
Secondary outcomes (4)
The overall responder rate
The overall responder rate after 2 weeks of Proton Pump Inhibitor empirical treatment
Measured: After 2 weeks of Proton Pump Inhibitor empirical treatment
The proportion of patients in each Gerd Q cut-off range at each visit
The proportion of patients in each Gerd Q cut-off range at each visit (Gerd Q range: ≤2; 3-7; 8-10; 11-18)
Measured: At each visit (baseline, 2 weeks and 4 weeks)
The responder rate of different Proton Pump Inhibitor empirical treatment
The responder rate respectively after 2 and 4 weeks of different Proton Pump Inhibitor empirical treatment
Measured: After 2 and 4 weeks of different PPIs empirical treatment
The median time to response overall and for different Proton Pump Inhibitor, respectively
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
Measured: During 4 weeks of whole study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start4 Dec 2015
- Primary completion28 Dec 2016
- Study completion28 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Typical Symptoms of GERD (GERD Q >= 8)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duowu Zou, leading PI, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606851
- Sponsor's protocol ID
- D1844R00002
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT02606851
- Acronym / sponsor ID
- D1844R00002
- Keywords
- Proton Pump Inhibitor, GERD, GERD Q
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
The overall responder rate
Time frame: After 2 weeks of Proton Pump Inhibitor empirical treatment
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 responder rate of different Proton Pump Inhibitor empirical treatment
Time frame: After 2 and 4 weeks of different PPIs empirical treatment
The median time to response overall and for different Proton Pump Inhibitor, respectively
Time frame: During 4 weeks of whole study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- GID1844R00002 CSR-Synopsis\_final 1Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duowu Zou, leading PI principal investigator
Changhai Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Typical Symptoms of GERD (GERD Q >= 8), run by AstraZeneca at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall responder rate (time frame: After 4 weeks of Proton Pump Inhibitor empirical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.