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

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ClinicalTrials.gov Identifier: NCT01119768
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Erosive Reflux Disease Chronic Gastritis Drug: Esomeprazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


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

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, 2 weeks and 24 weeks follow up




Primary Outcome Measures :
  1. Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. [ Time Frame: 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 :
  1. The Success Rate in Whole Study Duration. [ Time Frame: 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.

  2. Time to First Relapse. [ Time Frame: 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


  3. Symptom Relief Rate in 2 Treatment Regimens. [ Time Frame: 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.

  4. Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group. [ Time Frame: 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.

  5. Number of Patients With Unscheduled Hospital Visit(s) [ Time Frame: from baseline to week 24 after end of treatment ]
  6. Percentage of Patients Satisfaction [ Time Frame: 24 weeks after end of treatment ]
    Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.

  7. Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire [ Time Frame: 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.

  8. Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119768


Locations
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China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Shandong
Research Site
Jinan, Shandong, China
China, Shanxi
Research Site
Xian, Shanxi, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
China
Research Site
Beijin, China
Research Site
Shanghai, China
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Wenyu Guo AstraZeneca China MC
Principal Investigator: Prof. Yuan Yaozong Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01119768    
Other Study ID Numbers: D9612L00127
First Posted: May 10, 2010    Key Record Dates
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012
Last Verified: September 2012
Keywords provided by AstraZeneca:
GI
Nexium
Phase IV
Co-diagnosed NERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Gastritis
Gastritis, Atrophic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action