NCT01119768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 28, 2012

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

April 27, 2010

Results QC Date

June 1, 2012

Last Update Submit

September 26, 2012

Conditions

Non Erosive Reflux DiseaseChronic Gastritis

Keywords

GINexiumPhase IVCo-diagnosed NERD

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • The Success Rate in Whole Study Duration.

    24 weeks after end of treatment

  • Time to First Relapse.

    From baseline to 24 weeks after end of treatment

  • Symptom Relief Rate in 2 Treatment Regimens.

    8 weeks for arm 1, 2 weeks for arm 2

  • Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.

    2 and 8 weeks

  • Number of Patients With Unscheduled Hospital Visit(s)

    from baseline to week 24 after end of treatment

  • +3 more secondary outcomes

Study Arms (2)

Esomeprazole 8 weeks treatment

ACTIVE COMPARATOR

20 mg q.d. (quaque die) once a day dosing for 8 weeks

Drug: Esomeprazole

Esomeprazole 2 Weeks Treatment

ACTIVE COMPARATOR

20 mg q.d. (quaque die) once a day dosing for 2 weeks

Drug: Esomeprazole

Interventions

EsomeprazoleDRUG

20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment

Esomeprazole 8 weeks treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Jinan, Shandong, China

Location

Research Site

Xian, Shanxi, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Research Site

Beijin, China

Location

Research Site

Shanghai, China

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
az_trials_posting@astrazeneca.com

Study Officials

  • Wenyu Guo

    AstraZeneca China MC

    STUDY DIRECTOR

  • Prof. Yuan Yaozong

    Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2010

First Posted

May 10, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 28, 2012

Results First Posted

September 28, 2012

Record last verified: 2012-09

Locations

CN(8)