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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01119768
First received: April 27, 2010
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Non Erosive Reflux Disease
Chronic Gastritis
Drug: Esomeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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:
  • The Success Rate in Whole Study Duration. [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
    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. [ Time Frame: From baseline to 24 weeks after end of treatment ] [ Designated as safety issue: No ]

    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. [ Time Frame: 8 weeks for arm 1, 2 weeks for arm 2 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 and 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: from baseline to week 24 after end of treatment ] [ Designated as safety issue: No ]
  • Percentage of Patients Satisfaction [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 305
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119768

Locations
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
Study Director: Wenyu Guo AstraZeneca China MC
Principal Investigator: Prof. Yuan Yaozong Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01119768     History of Changes
Other Study ID Numbers: D9612L00127
Study First Received: April 27, 2010
Results First Received: June 1, 2012
Last Updated: September 26, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
GI
Nexium
Phase IV
Co-diagnosed NERD

Additional relevant MeSH terms:
Gastritis
Gastroesophageal Reflux
Gastritis, Atrophic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014