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:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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
Research Site
ARHUS C, Denmark
Research Site
BAGSVERD, Denmark
Research Site
BIRKEROD, Denmark
Research Site
BRONSHOJ, Denmark
Research Site
FARUM, Denmark
Research Site
FREDERICIA, Denmark
Research Site
FREDERIKSHAVN, Denmark
Research Site
FREDERIKSSUND, Denmark
Research Site
GRASTEN, Denmark
Research Site
HASLEV, Denmark
Research Site
HERNING, Denmark
Research Site
HINNERUP, Denmark
Research Site
KARLSLUNDE, Denmark
Research Site
KERTEMINDE, Denmark
Research Site
VIBY J, Denmark
Research Site
KOBENHAVN K, Denmark
Research Site
LOSNING, Denmark
Research Site
MIDDELFART, Denmark
Research Site
NESTVED, Denmark
Research Site
ODENSE C, Denmark
Research Site
RANDERS, Denmark
Research Site
ROSKILDE, Denmark
Research Site
RODOVRE, Denmark
Research Site
RUNGSTED KYST, Denmark
Research Site
SALTUM, Denmark
Research Site
SEBY, Denmark
Research Site
SINDAL, Denmark
Research Site
SOLROD STRAND, Denmark
Research Site
SVENDBORG, Denmark
Research Site
TASTRUP, Denmark
Research Site
TONDER, Denmark
Research Site
ULLERSLEV, Denmark
Research Site
VIBORG, Denmark
Research Site
KOLDING, 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

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

Keywords provided by AstraZeneca:

Acid Reflux
Nexium
Esomeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents

Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010