NCT00734097

Brief Summary

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
314

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_4

Geographic Reach
4 countries

10 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

Study Start

First participant enrolled

November 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 10, 2012

Completed
Last Updated

October 10, 2012

Status Verified

August 1, 2012

Enrollment Period

11 months

First QC Date

August 11, 2008

Results QC Date

September 25, 2009

Last Update Submit

September 10, 2012

Conditions

Gastroesophageal Reflux Disease

Keywords

heartburnrefluxprotonpumpinhibitor

Outcome Measures

Primary Outcomes (1)

  • Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment

    Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline

    At Baseline and 8 weeks

Secondary Outcomes (11)

  • Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment

    At Baseline and 4 weeks

  • Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment

    At Baseline and 8 weeks

  • Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment

    At Baseline and 4 weeks

  • Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.

    At Baseline and 4 weeks.

  • Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.

    At Baseline and 8 weeks.

  • +6 more secondary outcomes

Study Arms (1)

Nexium 40 mgs

EXPERIMENTAL
Drug: Esomeprazole 40 mgProcedure: Physical ExamOther: Quality of Life QuestionnairesProcedure: pregnancy test, if applicable

Interventions

Esomeprazole 40 mgDRUG

Once a day

Also known as: Nexium
Nexium 40 mgs
Physical ExamPROCEDURE

every visit

Nexium 40 mgs
Quality of Life QuestionnairesOTHER

every visit

Nexium 40 mgs
pregnancy test, if applicablePROCEDURE

as needed

Nexium 40 mgs

Eligibility Criteria

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

You may qualify if:

  • Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
  • informed consent
  • over 18 years of age

You may not qualify if:

  • Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
  • More than 1 other course of PPI treatment in the previous 12 month
  • previous use of esomeprazole
  • presence of alarm symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Buenos Aires, Argentina

Location

Research Site

Santiago, Chile

Location

Research Site

Temuco, Chile

Location

Research Site

Viña del Mar, Chile

Location

Research Site

Barranquilla, Colombia

Location

Research Site

Bogotá, Colombia

Location

Research Site

Medellín, Colombia

Location

Research Site

Barquisimeto, Venezuela

Location

Research Site

Caracas, Venezuela

Location

Research Site

San Cristóbal, Venezuela

Location

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Interventions

EsomeprazoleRestraint, PhysicalPregnancy Tests

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBehavior ControlTherapeuticsImmobilizationInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Obstetrical and Gynecological

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 10, 2012

Results First Posted

October 10, 2012

Record last verified: 2012-08

Locations

AR(1)CO(3)VE(3)CL(3)