Gastro-Oesophageal Reflux DiseasePhase 4NCT00384592
PPI Sequencing Study
A Phase 4 study testing Esomeprazole, Physical exam and Pregnancy test if applicable in people with Gastro-Oesophageal Reflux Disease, run by AstraZeneca at 14 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-Oesophageal Reflux Disease
- What is being tested?
- Esomeprazole, Physical exam and Pregnancy test if applicable
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- Sep 2006to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
- Informed consent
- Over 18 years of age
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Research Site
Allerton
Research Site
Ashford
Research Site
Atherstone
Research Site
Ayrshire
Research Site
Bath
Research Site
Blackpool
Research SIte
Bolton
Research Site
Coventry
Research Site
Fowey
Research SIte
Glasgow
Research Site
Hamilton
Research Site
Motherwell
Research Site
Stevenage
Research Site
Warminster
About this 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)
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.
- Conditions
- Gastro-Oesophageal Reflux Disease
- Being tested
- Esomeprazole, Physical exam, Pregnancy test if applicable
- Keywords
- heartburn, reflux, proton pump inhibitor, GERD, GORD
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Physical examProcedure or surgery
Pregnancy test if applicableProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Oesophageal Reflux DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rhiannon Rowsell, MD, Study director, AstraZenecaRoger Jones, MD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384592
- Sponsor's protocol ID
- D9612L00104
- Status last verified
- Mar 2009
- First submitted
- 5 Oct 2006
- Last updated
- 11 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00384592
- Acronym / sponsor ID
- D9612L00104
- Conditions
- Gastro-Oesophageal Reflux Disease
- Keywords
- heartburn, reflux, proton pump inhibitor, GERD, GORD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
- Informed consent
- Over 18 years of age
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
| Physical exam | Procedure or surgery | – |
| Pregnancy test if applicable | Procedure or surgery | – |
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhiannon Rowsell, MD study director
AstraZeneca
Roger Jones, MD principal investigator
UCL
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole, Physical exam and Pregnancy test if applicable in people with Gastro-Oesophageal Reflux Disease, run by AstraZeneca at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2009.