Gastroesophageal Reflux DiseasePHENIXNCT00768443
Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 32 sites in Croatia.
Trial summary
This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 2,674 participants
- Where
- 32 sitesCroatia
- Study dates
- Sep 2008to Feb 2009
- Phase
- Observational
- 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
Study population: PPI-treated patients consulting with persistent GERD symptoms in Primary Care. The patients must have a diagnosis of GERD with predominant typical GERD symptoms and fail to obtain satisfactory symptomatic response after the first full course of standard dose PPI. The patients must have been on continuous PPI treatment with unchanged doses according to local labelling during the last 4-8 weeks prior to the enrolment visit.
Who may be able to join
- Provision of informed consent
- Subjects with a diagnosis of GERD and with predominant typical GERD symptoms: heartburn/regurgitation
- Subjects who fail to obtain satisfactory symptomatic response after their first full course (4-8 weeks) of standard dose PPI (once a day)
Who cannot join
- Inability to read and/or understand Patient Reported Outcomes questionnaires
- Subjects where the only reason for the visit is renewing the prescription
- A history of an incomplete response to PPI treatment prior to current course of treatment
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Croatia32 sites
Research Site
Bjelovar
Research Site
Bulinec
Research Site
Crikvenica
Research Site
Daruvar
Research Site
Delnice
Research Site
Garešnica
Research Site
Gospić
Research Site
Ivanec
Research Site
Kalnik
Research Site
Karlovac
Research Site
Konjšćina
Research Site
Koprivnica
Research Site
Krapina
Research Site
Lovran
Research Site
Ludbreg
Research Site
Nedelišće
Research Site
Opatija
Research Site
OriovacGornja Vrba
Research Site
OtokPrivlakaIlokVukovarRetkovciGunjGarcin
Research Site
Pregrada
Research Site
PulaPorecPazinLabinRovinj
Research Site
Rijeka
Research Site
Samobor
Research Site
SenjVodiceTrogirSinjImotskiMokosicaPloceMetkovic
Research Site
Sisak
Research Site
SlavonskibrodOsijekVisnjevacKoskaDonji miholjacPleternicaVelik
Research Site
VarazdinCakovec
Research Site
Virje
Research Site
Zabok
Research Site
ZadarSibenikDubrovnik
Research Site
Zagreb
Research Site
Zlatar
About this study
Official title: Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care
This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms..
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, PPI
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms
Measured: Once, at first visit
Secondary outcomes (3)
To describe the frequency and severity of extra-oesophageal and/or atypical GERD symptoms and to assess the concordance between patient-reported and physician-reported symptom load
Measured: Once, at first visit
To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit
Measured: Once, at first visit
To describe the impact of persistent GERD symptoms on work productivity
Measured: Once, at first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,674 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768443
- Sponsor's protocol ID
- NIS-GHR-NEX-2008/1
- Acronym
- PHENIX
- Status last verified
- Dec 2010
- First submitted
- 7 Oct 2008
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care
- ClinicalTrials.gov ID
- NCT00768443
- Acronym / sponsor ID
- PHENIX / NIS-GHR-NEX-2008/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, PPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,674 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Oct 2008 (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.
This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms..
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PPI-treated patients consulting with persistent GERD symptoms in Primary Care. The patients must have a diagnosis of GERD with predominant typical GERD symptoms and fail to obtain satisfactory symptomatic response after the first full course of standard dose PPI. The patients must have been on continuous PPI treatment with unchanged doses according to local labelling during the last 4-8 weeks prior to the enrolment visit.
Key inclusion criteria (3 listed)
- Provision of informed consent
- Subjects with a diagnosis of GERD and with predominant typical GERD symptoms: heartburn/regurgitation
- Subjects who fail to obtain satisfactory symptomatic response after their first full course (4-8 weeks) of standard dose PPI (once a day)
Key exclusion criteria (3 listed)
- Inability to read and/or understand Patient Reported Outcomes questionnaires
- Subjects where the only reason for the visit is renewing the prescription
- A history of an incomplete response to PPI treatment prior to current course of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms
Time frame: Once, at first visit
3 secondary outcomes
To describe the frequency and severity of extra-oesophageal and/or atypical GERD symptoms and to assess the concordance between patient-reported and physician-reported symptom load
Time frame: Once, at first visit
To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit
Time frame: Once, at first visit
To describe the impact of persistent GERD symptoms on work productivity
Time frame: Once, at first visit
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 7 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 32 sites in Croatia.
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 3 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 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Croatia. 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.
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?
To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms (time frame: Once, at first visit). 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 7 Dec 2010.