Clinical trial NCT00318968: Nexium RESPONSE Trial
Official title: Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: GERD
Keywords: Acid Reflux
Nexium
Esomeprazole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Albek
country: Denmark
facility: Research Site
city: Alborg
country: Denmark
facility: Research Site
city: Ans by
country: Denmark
facility: Research Site
city: Arhus C
country: Denmark
facility: Research Site
city: Bagsverd
country: Denmark
facility: Research Site
city: Birkerod
country: Denmark
facility: Research Site
city: Bronshoj
country: Denmark
facility: Research Site
city: Farum
country: Denmark
facility: Research Site
city: Fredericia
country: Denmark
facility: Research Site
city: Frederikshavn
country: Denmark
facility: Research Site
city: Frederikssund
country: Denmark
facility: Research Site
city: Grasten
country: Denmark
facility: Research Site
city: Haslev
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Hinnerup
country: Denmark
facility: Research Site
city: Karlslunde
country: Denmark
facility: Research Site
city: Kerteminde
country: Denmark
facility: Research Site
city: Kobenhavn K
country: Denmark
facility: Research Site
city: Kolding
country: Denmark
facility: Research Site
city: Losning
country: Denmark
facility: Research Site
city: Middelfart
country: Denmark
facility: Research Site
city: Nestved
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Randers
country: Denmark
facility: Research Site
city: Rodovre
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
facility: Research Site
city: Rungsted Kyst
country: Denmark
facility: Research Site
city: Saltum
country: Denmark
facility: Research Site
city: Seby
country: Denmark
facility: Research Site
city: Sindal
country: Denmark
facility: Research Site
city: Solrod Strand
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Tastrup
country: Denmark
facility: Research Site
city: Tonder
country: Denmark
facility: Research Site
city: Ullerslev
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Viby J
country: Denmark
facility: Research Site
Study officials:
affiliation: Charlottenlund Research Site
name: Villy Meineche Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Denmark
name: Stig Waldorff, MD
role: STUDY_DIRECTOR
References:
citation: Bytzer P, Langkilde LK, Christensen E, Meineche-Schmidt V. Work productivity improvement after acid suppression in patients with uninvestigated dyspepsia. Dan Med J. 2012 Jul;59(7):A4461.
citation: Meineche-Schmidt V, Christensen E, Bytzer P. Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(1):41-9. doi: 10.1111/j.1365-2036.2010.04501.x. Epub 2010 Oct 29.