Nexium RESPONSE Trial

Condition(s) targeted: GERD

Intervention: Esomeprazole (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Villy Meineche Schmidt, MD, Principal Investigator, Affiliation: Charlottenlund Research Site
Stig Waldorff, MD, Study Director, Affiliation: AstraZeneca, Denmark

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

Official title: Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care

Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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, KOLDING, 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, VIBY J, Denmark

Starting date: May 2006
Last updated: April 9, 2008