Nexium RESPONSE Trial

NCT ID: NCT00318968

Last Updated: 2009-01-26

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

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-11-30

Brief Summary

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The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.

Detailed Description

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Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Esomeprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent

Exclusion Criteria

* Alarm symptoms
* Pregnancy
* Contraindications to Nexium
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Villy Meineche Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Charlottenlund Research Site

Stig Waldorff, MD

Role: STUDY_DIRECTOR

AstraZeneca, Denmark

Locations

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Research Site

Aabenraa, , Denmark

Site Status

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Aalborg, , Denmark

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Albek, , Denmark

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Ans, , Denmark

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Arhus C, , Denmark

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Bagsværd, , Denmark

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Birkerød, , Denmark

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Brønshøj, , Denmark

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Farum, , Denmark

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Fredericia, , Denmark

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Frederikshavn, , Denmark

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Frederikssund, , Denmark

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Gråsten, , Denmark

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Haslev, , Denmark

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Herning, , Denmark

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Hinnerup, , Denmark

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Karlslunde, , Denmark

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Kerteminde, , Denmark

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Kobenhavn K, , Denmark

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Kolding, , Denmark

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Løsning, , Denmark

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Middelfart, , Denmark

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Næstved, , Denmark

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Odense C, , Denmark

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Randers, , Denmark

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Roskilde, , Denmark

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Rungsted Kyst, , Denmark

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Rødovre Municipality, , Denmark

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Saltum, , Denmark

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SEBY, , Denmark

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Sindal, , Denmark

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Solrød Strand, , Denmark

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Svendborg, , Denmark

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Tåstrup, , Denmark

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Tønder, , Denmark

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Ullerslev, , Denmark

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Viborg, , Denmark

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Viby J, , Denmark

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Countries

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Denmark

References

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Bytzer P, Langkilde LK, Christensen E, Meineche-Schmidt V. Work productivity improvement after acid suppression in patients with uninvestigated dyspepsia. Dan Med J. 2012 Jul;59(7):A4461.

Reference Type DERIVED
PMID: 22759841 (View on PubMed)

Meineche-Schmidt V, Christensen E, Bytzer P. Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(1):41-9. doi: 10.1111/j.1365-2036.2010.04501.x. Epub 2010 Oct 29.

Reference Type DERIVED
PMID: 21083590 (View on PubMed)

Other Identifiers

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RESPONSE

Identifier Type: -

Identifier Source: secondary_id

D9612L00076

Identifier Type: -

Identifier Source: org_study_id

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