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

Chronic Gastritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119768
• Other study ID #: D9612L00127
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2010
• Last updated: September 26, 2012
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Gastritis
• Gastritis
• Gastroesophageal Reflux
• Non Erosive Reflux Disease

Intervention

Drug:
• Esomeprazole
20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
• Esomeprazole
20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up

Locations

Country	Name	City	State
China	Research Site	Beijin
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Jinan	Shandong
China	Research Site	Nanjing	Jiangsu
China	Research Site	Shanghai
China	Research Site	Wuhan	Hubei
China	Research Site	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Patients With Unscheduled Hospital Visit(s)		from baseline to week 24 after end of treatment	No
Secondary	Percentage of Patients Satisfaction	Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.	24 weeks after end of treatment	No
Secondary	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	No
Secondary	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	No