NCT00392002

Brief Summary

To characterize the burden of disease in GERD patients of prescription therapy'

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

2 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

October 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

First QC Date

October 24, 2006

Last Update Submit

January 24, 2008

Conditions

Gastroesophageal Reflux

Keywords

GERD

Outcome Measures

Primary Outcomes (1)

  • To compare the improvement in burden of overall GERD symptoms after 4 weeks of treatment with Esomeprazole verses maintenance of current therapy in subjects with persistent GERD symptoms.

Secondary Outcomes (1)

  • To examine the relationship of the severity and frequency of GERD symptoms to treatment, at national, and regional levels.

Interventions

EsomeprazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent, 18 years or older, diagnosis of GERD

You may not qualify if:

  • Peptic ulcer disease, upper gastrointestinal surgery, malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Mississauga, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Moayyedi P, Hunt R, Armstrong D, Lei Y, Bukoski M, White R. The impact of intensifying acid suppression on sleep disturbance related to gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2013 Apr;37(7):730-7. doi: 10.1111/apt.12254. Epub 2013 Feb 21.

    PMID: 23432146DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • AstraZeneca Canada Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 25, 2006

Study Start

October 1, 2005

Study Completion

May 1, 2007

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

CA(2)