NCT00318968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2006

Geographic Reach
1 country

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 26, 2009

Status Verified

January 1, 2009

First QC Date

April 26, 2006

Last Update Submit

January 23, 2009

Conditions

GERD

Keywords

Acid RefluxNexiumEsomeprazole

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

EsomeprazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Alarm symptoms
  • Pregnancy
  • Contraindications to Nexium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Research Site

Aabenraa, Denmark

Location

Research Site

Aalborg, Denmark

Location

Research Site

Albek, Denmark

Location

Research Site

Ans, Denmark

Location

Research Site

Arhus C, Denmark

Location

Research Site

Bagsværd, Denmark

Location

Research Site

Birkerød, Denmark

Location

Research Site

Brønshøj, Denmark

Location

Research Site

Farum, Denmark

Location

Research Site

Fredericia, Denmark

Location

Research Site

Frederikshavn, Denmark

Location

Research Site

Frederikssund, Denmark

Location

Research Site

Gråsten, Denmark

Location

Research Site

Haslev, Denmark

Location

Research Site

Herning, Denmark

Location

Research Site

Hinnerup, Denmark

Location

Research Site

Karlslunde, Denmark

Location

Research Site

Kerteminde, Denmark

Location

Research Site

Kobenhavn K, Denmark

Location

Research Site

Kolding, Denmark

Location

Research Site

Løsning, Denmark

Location

Research Site

Middelfart, Denmark

Location

Research Site

Næstved, Denmark

Location

Research Site

Odense C, Denmark

Location

Research Site

Randers, Denmark

Location

Research Site

Roskilde, Denmark

Location

Research Site

Rungsted Kyst, Denmark

Location

Research Site

Rødovre Municipality, Denmark

Location

Research Site

Saltum, Denmark

Location

Research Site

SEBY, Denmark

Location

Research Site

Sindal, Denmark

Location

Research Site

Solrød Strand, Denmark

Location

Research Site

Svendborg, Denmark

Location

Research Site

Tåstrup, Denmark

Location

Research Site

Tønder, Denmark

Location

Research Site

Ullerslev, Denmark

Location

Research Site

Viborg, Denmark

Location

Research Site

Viby J, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 22759841DERIVED

  • 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.

    PMID: 21083590DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Villy Meineche Schmidt, MD

    Charlottenlund Research Site

    PRINCIPAL INVESTIGATOR

  • Stig Waldorff, MD

    AstraZeneca, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

May 1, 2006

Study Completion

November 1, 2007

Last Updated

January 26, 2009

Record last verified: 2009-01

Locations

DK(38)