Official Title: “An Open Label, Multicentre Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole 40 mg
  • Once a day
• Procedure: Physical Exam
  • every visit
• Other: Quality of Life Questionnaires
  • every visit
• Procedure: pregnancy test, if applicable
  • as needed

Arms, Groups and Cohorts in this Clinical Trial

• Other: Nexium 40 mgs

Primary Measures

• The primary objective of this study is to asses the change in the frequency of heartburn from entry to the end of the study, after 8-weeks treatment with Esomeprazole 40 mg compared to previous full dose PPI treatment given once daily.
  • Time Frame: Every 4 weeks
    Safety Issue?: No

Secondary Measures

• Change in: · 1) frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry· 2) symptom control from baseline to 4 and 8 weeks using QoL questionnaires
  • Time Frame: Every 4 weeks
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00734097

Study ID Number: D9612L00116

ClinicalTrials.gov Identifier: NCT00734097

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica