PPI Sequencing Study
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)
1 other identifier
interventional
100
1 country
14
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2006
Shorter than P25 for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 5, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 11, 2009
March 1, 2009
8 months
October 5, 2006
March 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Interventions
Eligibility Criteria
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
- AstraZenecalead
Study Sites (14)
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
Fowey, United Kingdom
Research SIte
Glasgow, United Kingdom
Research Site
Hamilton, United Kingdom
Research Site
Motherwell, United Kingdom
Research Site
Stevenage, United Kingdom
Research Site
Warminster, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rhiannon Rowsell, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Roger Jones, MD
UCL
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2006
First Posted
October 6, 2006
Study Start
September 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
March 11, 2009
Record last verified: 2009-03