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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Gastritis; Non Erosive Reflux Disease
• Intervention / Treatment: Drug: Esomeprazole; Drug: Esomeprazole

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 Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijin, China
    • Research Site
  • Shanghai, China
    • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China
      • Research Site
  • Hubei
    • Wuhan, Hubei, China
      • Research Site
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Research Site
  • Shandong
    • Jinan, Shandong, China
      • Research Site
  • Shanxi
    • Xian, Shanxi, China
      • Research Site
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Esomeprazole 8 weeks treatment; 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Drug: Esomeprazole; 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment; Drug: Esomeprazole; 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up
ACTIVE_COMPARATOR: Esomeprazole 2 Weeks Treatment; 20 mg q.d. (quaque die) once a day dosing for 2 weeks	Drug: Esomeprazole; 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment; Drug: Esomeprazole; 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	2 and 8 weeks
Number of Patients With Unscheduled Hospital Visit(s)		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.	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.	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.	16 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Wenyu Guo, AstraZeneca China MC; Principal Investigator: Prof. Yuan Yaozong, Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: April 27, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (ESTIMATE): May 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 28, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Phase IV; Nexium; GI; Co-diagnosed NERD
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastritis; Gastroesophageal Reflux; Gastritis, Atrophic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D9612L00127