PPI Sequencing Study

Condition(s) targeted: Gastro-Oesophageal Reflux Disease

Intervention: Esomeprazole (Drug); Physical exam (Procedure); Pregnancy test if applicable (Procedure)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Rhiannon Rowsell, MD, Study Director, Affiliation: AstraZeneca
Roger Jones, MD, Principal Investigator, Affiliation: UCL

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.

Official title: A Study to Assess the Effectiveness of Esomeprazole 40 mg Once Daily in Subjects With Continuing Gastroesophageal Reflux Disease (GORD) Symptoms Following Treatment Wit a Previous Full Dose Proton Pump Inhibitor (PPI)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily

Secondary outcome:

Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry

Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Research Site, FOWEY, United Kingdom

Research Site, HAMILTON, United Kingdom

Research Site, MOTHERWELL, United Kingdom

Research Site, WARMINSTER, United Kingdom

Research Site, ALLERTON, United Kingdom

Research Site, ASHFORD, United Kingdom

Research Site, ATHERSTONE, United Kingdom

Research Site, AYRSHIRE, United Kingdom

Research Site, BATH, United Kingdom

Research Site, BLACKPOOL, United Kingdom

Research SIte, BOLTON, United Kingdom

Research Site, COVENTRY, United Kingdom

Research SIte, GLASGOW, United Kingdom

Research Site, STEVENAGE, United Kingdom

Starting date: September 2006
Last updated: April 23, 2007