Gastroesophageal RefluxPhase 4NCT00392002
Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response
A Phase 4 study testing Esomeprazole in people with Gastroesophageal Reflux, run by AstraZeneca at 2 sites in Canada.
Trial summary
To characterize the burden of disease in GERD patients of prescription therapy' Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Esomeprazole
- How many people
- 2,000 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2005to May 2007
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent, 18 years or older, diagnosis of GERD
Who cannot join
- Peptic ulcer disease, upper gastrointestinal surgery, malignancy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Cluster-Randomized Study to Examine National Characteristics and Outcome Measures of GERD Patients Utilizing the PPI Acid Suppression Symptom (PASS) Test for Response [EncomPASS].
To characterize the burden of disease in GERD patients of prescription therapy'
- Conditions
- Gastroesophageal Reflux
- Being tested
- Esomeprazole
- Keywords
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the improvement in burden of overall GERD symptoms after 4 weeks of treatment with Esomeprazole verses maintenance of current therapy in subjects with persistent GERD symptoms.
Secondary outcomes (1)
To examine the relationship of the severity and frequency of GERD symptoms to treatment, at national, and regional levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startOct 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Canada Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392002
- Sponsor's protocol ID
- D9612L00096
- Other IDs
- EncomPASS
- Status last verified
- Jan 2008
- First submitted
- 24 Oct 2006
- Last updated
- 25 Jan 2008
- Results posted
- No
Publications
Moayyedi P, Hunt R, Armstrong D, Lei Y, Bukoski M, White R. The impact of intensifying acid suppression on sleep disturbance related to gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2013 Apr;37(7):730-7. doi: 10.1111/apt.12254. Epub 2013 Feb 21.
PubMed 23432146