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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01119768

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 IV

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:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Symptom control rate in 8 wks treatment regimen group, compared with 2 wks treatment regimen group after 24 wks on-demand maintenance treatment/ follow up. Controlled patients are defined as patients with all items ≤1 in A and C category of Gerd [ Time Frame: Gerd Q questionnaire will be taken at 8 weeks ] [ Designated as safety issue: No ]
Symptom control rate in 8 wks treatment regimen group, compared with 2 wks treatment regimen group after 24 wks on-demand maintenance treatment/ follow up. Controlled patients are defined as patients with all items ≤1 in A and C category of Gerd [ Time Frame: Gerd Q questionnaire will be taken at 16 weeks ] [ Designated as safety issue: No ]
Symptom control rate in 8 wks treatment regimen group, compared with 2 wks treatment regimen group after 24 wks on-demand maintenance treatment/ follow up. Controlled patients are defined as patients with all items ≤1 in A and C category of Gerd [ Time Frame: Gerd Q questionnaire will be taken at 24 weeks ] [ Designated as safety issue: No ]
Symptom control rate in 8 wks treatment regimen group, compared with 2 wks treatment regimen group after 24 wks on-demand maintenance treatment/ follow up. Controlled patients are defined as patients with all items ≤1 in A and C category of Gerd [ Time Frame: Gerd Q questionnaire will be taken at 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The success rate in 8 weeks treatment regimen group [ Time Frame: After 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled after 24 weeks maintenance treatment/follow up period ] [ Designated as safety issue: No ]
The success rate in 8 weeks treatment regimen group, compared with 2 weeks treatment regimen group after 24 weeks on-demand maintenance treatment/ follow up. Success is defined as patients who relieved after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled after 24 weeks maintenance treatment/follow up period.
Time to first relapse, defined as the time to the patients first come to see the investigator because of symptom recur and need for treatment after 8 weeks or 2 weeks treatment in the two treatment regimen groups. [ Time Frame: First relapse ] [ Designated as safety issue: No ]
The symptom control rate after 8 and 16 weeks on-demand maintenance treatment/ follow up in the two different treatment regimen groups. Controlled patients are defined as patients with all items ≤1 in A and C category of GERD Q. [ Time Frame: Gerd Q ] [ Designated as safety issue: No ]
The symptom relief rate after 8 weeks or 2 weeks treatment in the two treatment regimen groups. Symptoms relief are defined as no more than one day with mild symptoms of GERD during the previous 7 days. [ Time Frame: Symptoms of GERD after 2 or 8 weeks treatment in two groups ] [ Designated as safety issue: No ]

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: 1 Esomeprazole 8 weeks treatment	Drug: Esomeprazole 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
Active Comparator: 2 Esomeprazole 2 weeks treatment	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 Province
Research Site
Guangzhou, Guangdong Province, China
China, Hubei Province
Research Site
Wuhan, Hubei Province, China
China, Jiangsu Province
Research Site
Nanjing, Jiangsu Province, China
China, Shandong Province
Research Site
Jinan, Shandong Province, China
China, Shanxi Province
Research Site
Xian, Shanxi Province, China
China, Zhejiang Province
Research Site
Hangzhou, Zhejiang Province, 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
Last Updated:	September 26, 2011
Health Authority:	China: State 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 February 09, 2012