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Nexium RESPONSE Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318968
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : January 26, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
GERD Drug: Esomeprazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care
Study Start Date : May 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00318968

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Research Site
Aabenraa, Denmark
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Aalborg, Denmark
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Albek, Denmark
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Alborg, Denmark
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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
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Tonder, Denmark
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Ullerslev, Denmark
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Viborg, Denmark
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Viby J, Denmark
Sponsors and Collaborators
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Principal Investigator: Villy Meineche Schmidt, MD Charlottenlund Research Site
Study Director: Stig Waldorff, MD AstraZeneca, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00318968    
Other Study ID Numbers: D9612L00076
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009
Keywords provided by AstraZeneca:
Acid Reflux
Additional relevant MeSH terms:
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Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action