Non Erosive Reflux DiseasePhase 4NCT01119768
Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
A Phase 4 study testing Esomeprazole in people with Non Erosive Reflux Disease and Chronic Gastritis, run by AstraZeneca at 8 sites in China.
Trial summary
To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Erosive Reflux Disease, Chronic Gastritis
- What is being tested?
- Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 8 sitesChina
- Study dates
- Apr 2010to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heartburn and/or regurgitation symptoms last for at least 3 months
- Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8
Who cannot join
- Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded
- If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Research Site
Beijin
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Jinan, Shandong
Research Site
Nanjing, Jiangsu
Research Site
Shanghai
Research Site
Wuhan, Hubei
Research Site
Xian, Shanxi
About this study
Official title: A Multicenter, Randomized, Open-label Phase IV Study Exploring Symptom Control Rate in Co-diagnosed NERD and Chronic Gastritis Patients Treated With 8 Weeks Esomeprazole Treatment Regimen and 2 Weeks Esomeprazole Treatment Regimen
To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.
Read the detailed description
A multicenter, randomized, open-label Phase IV study exploring symptom control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.
- Conditions
- Non Erosive Reflux Disease, Chronic Gastritis
- Being tested
- Esomeprazole
- Keywords
- GI, Nexium, Phase IV, Co-diagnosed NERD
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
EsomeprazoleDrug
20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole 8 weeks treatment | Active comparator | 20 mg q.d. (quaque die) once a day dosing for 8 weeks Receives: Drug: Esomeprazole |
| Esomeprazole 2 Weeks Treatment | Active comparator | 20 mg q.d. (quaque die) once a day dosing for 2 weeks Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
Measured: 24 weeks
Secondary outcomes (8)
The Success Rate in Whole Study Duration.
Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.
Measured: 24 weeks after end of treatment
Time to First Relapse.
Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.
Time to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint
Measured: From baseline to 24 weeks after end of treatment
Symptom Relief Rate in 2 Treatment Regimens.
Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.
Measured: 8 weeks for arm 1, 2 weeks for arm 2
Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.
Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.
Measured: 2 and 8 weeks
Number of Patients With Unscheduled Hospital Visit(s)
Measured: from baseline to week 24 after end of treatment
Percentage of Patients Satisfaction
Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.
Measured: 24 weeks after end of treatment
Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
Measured: 8 weeks
Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Erosive Reflux DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenyu Guo, Study director, AstraZeneca China MCProf. Yuan Yaozong, Principal investigator, Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119768
- Sponsor's protocol ID
- D9612L00127
- Status last verified
- Sep 2012
- First submitted
- 27 Apr 2010
- Last updated
- 28 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Phase IV Study Exploring Symptom Control Rate in Co-diagnosed NERD and Chronic Gastritis Patients Treated With 8 Weeks Esomeprazole Treatment Regimen and 2 Weeks Esomeprazole Treatment Regimen
- ClinicalTrials.gov ID
- NCT01119768
- Acronym / sponsor ID
- D9612L00127
- Conditions
- Non Erosive Reflux Disease, Chronic Gastritis
- Keywords
- GI, Nexium, Phase IV, Co-diagnosed NERD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 28 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.
Detailed description
A multicenter, randomized, open-label Phase IV study exploring symptom control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole 8 weeks treatment | Active comparator | Drug: Esomeprazole20 mg q.d. (quaque die) once a day dosing for 8 weeks |
| Esomeprazole 2 Weeks Treatment | Active comparator | Drug: Esomeprazole20 mg q.d. (quaque die) once a day dosing for 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heartburn and/or regurgitation symptoms last for at least 3 months
- Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8
Key exclusion criteria (2 listed)
- Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded
- If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment | Drug | Esomeprazole 8 weeks treatment |
| Esomeprazole20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up | Drug | Esomeprazole 2 Weeks Treatment |
Primary outcome
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
Time frame: 24 weeks
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
8 secondary outcomes
The Success Rate in Whole Study Duration.
Time frame: 24 weeks after end of treatment
Time to First Relapse.
Time frame: From baseline to 24 weeks after end of treatment
Symptom Relief Rate in 2 Treatment Regimens.
Time frame: 8 weeks for arm 1, 2 weeks for arm 2
Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.
Time frame: 2 and 8 weeks
Number of Patients With Unscheduled Hospital Visit(s)
Time frame: from baseline to week 24 after end of treatment
Percentage of Patients Satisfaction
Time frame: 24 weeks after end of treatment
Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire
Time frame: 8 weeks
Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Non Erosive Reflux Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
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Not yet recruiting
Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
Non-Erosive Gastroesophageal Reflux Disease (NERD)
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
Recruiting
QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)
Nocturnal Symptoms of GERD, Sleep Disorders in GERD
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.
Wenyu Guo study director
AstraZeneca China MC
Prof. Yuan Yaozong principal investigator
Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole in people with Non Erosive Reflux Disease and Chronic Gastritis, run by AstraZeneca at 8 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 2 inclusion and 2 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 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. (time frame: 24 weeks). 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 28 Sep 2012.