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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01119768
Other study ID # D9612L00127
Secondary ID
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


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
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