Nexium RESPONSE Trial
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00318968
First received: April 26, 2006
Last updated: January 23, 2009
Last verified: January 2009
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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 4 |
| 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
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 | |
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| 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
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):
| 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 May 19, 2013