GERD Clinical Trial
Official title:
Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care
| Verified date | January 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | November 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| 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 | Kobenhavn K | |
| Denmark | Research Site | Kolding | |
| Denmark | Research Site | Losning | |
| Denmark | Research Site | Middelfart | |
| Denmark | Research Site | Nestved | |
| Denmark | Research Site | Odense C | |
| Denmark | Research Site | Randers | |
| Denmark | Research Site | Rodovre | |
| Denmark | Research Site | Roskilde | |
| 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 | Viby J |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)). |
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