NCT00318084

Brief Summary

The purpose of this study is to determine the diagnostic value of two week treatment with Nexium as a confirmatory test for patients with suspected reflux disease.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
Last Updated

August 17, 2007

Status Verified

August 1, 2007

First QC Date

April 25, 2006

Last Update Submit

August 15, 2007

Conditions

GERD

Keywords

Gastroesophageal reflux diseaseHeartburnAcid-related diseasesAcid reflux diseaseNexium

Outcome Measures

Primary Outcomes (1)

  • Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard.

Secondary Outcomes (2)

  • To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms.

  • Obtain information on patient satisfaction, the course of reflux symptoms, the consumption of acid suppressing drugs, the disease-related quality of life at a follow up periods of 3 months in patients with a positive and negative PPI test.

Interventions

EsomeprazoleDRUG
Ambulatory 24-hour esophageal pH-monitoringPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Symptoms suggestive for gastric acid reflux disease during 2 or more days per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Interventions

EsomeprazoleAmbulatory Care Facilities

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-RingHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • AstraZeneca Netherlands Medical Director

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 26, 2006

Study Start

January 1, 2003

Last Updated

August 17, 2007

Record last verified: 2007-08

Locations

NL(1)