PPI Test in GP Patients

NCT ID: NCT00318084

Last Updated: 2007-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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GERD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Esomeprazole

Intervention Type DRUG

Ambulatory 24-hour esophageal pH-monitoring

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion
* Treatment with a PPI for more than 30 days within the last 3 months prior to inclusion
* History of proven peptic ulcer disease, unless successfully treated with Helicobacter pylori eradication longer than 1 month before inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Netherlands Medical Director

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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25N54

Identifier Type: -

Identifier Source: org_study_id