Phase 4
N=305
Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
Non Erosive Reflux Disease · Chronic Gastritis
Bottom Line
View on ClinicalTrials.gov: NCT01119768 ↗Enrolled (actual)
305
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. — 94.9; 87.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Esomeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. |
94.9; 87.3 | — |
| SECONDARY The Success Rate in Whole Study Duration. |
83.8; 72.8 | — |
| SECONDARY Time to First Relapse. |
NA; 57 | — |
| SECONDARY Symptom Relief Rate in 2 Treatment Regimens. |
88.3; 83.4 | — |
| SECONDARY Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group. |
54.5; 88.3 | — |
| SECONDARY Number of Patients With Unscheduled Hospital Visit(s) |
59; 80 | — |
| SECONDARY Percentage of Patients Satisfaction |
100; 96; 48.5; 24.6 | — |
| SECONDARY Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire |
80.1; 75.4 | — |
| SECONDARY Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire |
85.3; 80.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01119768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.