Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients

Phase 4

Completed

• Conditions: Non Erosive Reflux Disease; Chronic Gastritis
• Interventions: Drug: Esomeprazole

• Registration Number: NCT01119768
• Lead Sponsor: AstraZeneca

Brief 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.

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-06-01
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-26
• Last Update Submitted: 2012-09-26
• Results First Posted: 2012-09-28
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole 2 Weeks Treatment	Esomeprazole	20 mg q.d. (quaque die) once a day dosing for 2 weeks
Esomeprazole 8 weeks treatment	Esomeprazole	20 mg q.d. (quaque die) once a day dosing for 8 weeks

Primary Outcome Measures

Name	Time	Method
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.	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.

Secondary Outcome Measures

Name	Time	Method
The Success Rate in Whole Study Duration.	24 weeks after end of treatment	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.
Time to First Relapse.	From baseline to 24 weeks after end of treatment	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
Symptom Relief Rate in 2 Treatment Regimens.	8 weeks for arm 1, 2 weeks for arm 2	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.
Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.	2 and 8 weeks	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.
Number of Patients With Unscheduled Hospital Visit(s)	from baseline to week 24 after end of treatment
Percentage of Patients Satisfaction	24 weeks after end of treatment	Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.
Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire	8 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.
Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire	16 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.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Shanghai, China