Nexium RESPONSE Trial

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00318968

Enrollment

1000

Registered

2006-04-27

Start date

2006-05-31

Completion date

2007-11-30

Last updated

2009-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

Acid Reflux, Nexium, Esomeprazole

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.

Interventions

DRUGEsomeprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026