NCT00243724

Brief Summary

Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen histological markers of esophageal epithelial acid-related disease in patients with upper GI symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

10 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, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

2.2 years

First QC Date

October 24, 2005

Last Update Submit

March 25, 2009

Conditions

Gastroesophageal RefluxHeartburnDyspepsia

Keywords

immunohistochemicalerosive esophagitisAcid reflux disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline after 6 months in the level of ki-67 expression and histological markers of esophageal epithelial acid-related disease after acid-suppressive therapy with esomeprazole

Secondary Outcomes (1)

  • Changes in immunohistochemical markers of esophageal epithelial acid-related disease after 6 months treatment with different levels of acid suppression with esomeprazole

Interventions

EsomeprazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • years or older
  • history of upper GI symptoms

You may not qualify if:

  • Peptic ulcer disease
  • upper gastrointestinal surgery
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

Guelph, Ontario, Canada

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Kingston, Ontario, Canada

Location

Research Site

Mississauga, Ontario, Canada

Location

Research Site

North York, Ontario, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Pointe-Claire, Quebec, Canada

Location

Research Site

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburnDyspepsia

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 25, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

CA(10)