Nexium RESPONSE Trial - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00318968

Purpose

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

Condition	Intervention	Phase
GERD	Drug: Esomeprazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.

Secondary Outcome Measures:

To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).

Estimated Enrollment:	1000
Study Start Date:	May 2006
Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318968

Locations

Denmark
Research Site
Aabenraa, Denmark
Research Site
Aalborg, Denmark
Research Site
Albek, Denmark
Research Site
Alborg, Denmark
Research Site
Ans by, Denmark
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Arhus C, Denmark
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Bagsverd, Denmark
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Birkerod, Denmark
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Bronshoj, 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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Grasten, 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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Losning, Denmark
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Middelfart, Denmark
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Nestved, Denmark
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Odense C, Denmark
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Randers, Denmark
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Rodovre, Denmark
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Roskilde, Denmark
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Rungsted Kyst, Denmark
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Saltum, Denmark
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Seby, Denmark
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Sindal, Denmark
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Solrod Strand, Denmark
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Svendborg, Denmark
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Tastrup, Denmark
Research Site
Tonder, Denmark
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Ullerslev, Denmark
Research Site
Viborg, Denmark
Research Site
Viby J, Denmark

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Villy Meineche Schmidt, MD	Charlottenlund Research Site
Study Director:	Stig Waldorff, MD	AstraZeneca, Denmark

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Oct 29.

ClinicalTrials.gov Identifier:	NCT00318968 History of Changes
Other Study ID Numbers:	D9612L00076, RESPONSE
Study First Received:	April 26, 2006
Last Updated:	January 23, 2009
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Acid Reflux
Nexium
Esomeprazole

Additional relevant MeSH terms:

Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012