Back to resultsPPI Sequencing Study
Primary Purpose
Gastro-Oesophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Esomeprazole
Physical exam
Pregnancy test if applicable
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-Oesophageal Reflux Disease focused on measuring heartburn, reflux, proton pump inhibitor, GERD, GORD
Eligibility 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.
Sites / Locations
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Outcomes
Primary Outcome Measures
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 Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00384592
Brief Title
PPI Sequencing Study
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Oesophageal Reflux Disease
Keywords
heartburn, reflux, proton pump inhibitor, GERD, GORD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Type
Procedure
Intervention Name(s)
Physical exam
Intervention Type
Procedure
Intervention Name(s)
Pregnancy test if applicable
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry
Title
Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhiannon Rowsell, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roger Jones, MD
Organizational Affiliation
UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Allerton
Country
United Kingdom
Facility Name
Research Site
City
Ashford
Country
United Kingdom
Facility Name
Research Site
City
Atherstone
Country
United Kingdom
Facility Name
Research Site
City
Ayrshire
Country
United Kingdom
Facility Name
Research Site
City
Bath
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
Country
United Kingdom
Facility Name
Research SIte
City
Bolton
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Fowey
Country
United Kingdom
Facility Name
Research SIte
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Hamilton
Country
United Kingdom
Facility Name
Research Site
City
Motherwell
Country
United Kingdom
Facility Name
Research Site
City
Stevenage
Country
United Kingdom
Facility Name
Research Site
City
Warminster
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
PPI Sequencing Study
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