GERDProspectNCT00697008
Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study
An observational study of GERD, run by AstraZeneca at 29 sites in Spain.
Trial summary
To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- GERD
- How many people
- 300 participants
- Where
- 29 sitesSpain
- Study dates
- Dec 2007to Jan 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with typical GERD symptoms consulting in specialized care setting and are managed following the new local GERD guidelines
Who may be able to join
- Signed informed consent
- Age above 18
- Subjects with typical GERD symptoms: predominant heartburn/regurgitation
- Naive patients or off PPI treatment in the last 2 months
Who cannot join
- Inability to read and understand PRO instructions
- Patient not suitable to be treated following the AEG guidelines
- Concomitant treatment with NSAID, antiplatelet drugs
- Previous PPI failure
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites
Research Site
A Coruña, La Coruna
Research Site
Alzira, Valencia
Research Site
Badajoz, Badajoz
Research Site
Barakaldo, Vizcaya
Research Site
Barcelona, Barcelona
Research Site
Bilbao, Vizcaya
Research Site
Cabra, Cordoba
Research Site
Cadiz, Cadiz
Research Site
Córdoba, Cordoba
Research Site
Donostia / San Sebastian, Guipuzcoa
Research Site
Huelva, Huelva
Research Site
Huesca, Huesca
Research Site
Jerez de la Frontera, Cadiz
Research Site
LA Cuesta de Arguijon, Tenerife
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Marbella, Malaga
Research Site
Murcia, Murcia
Research Site
Oviedo, Principality of Asturias
Research Site
Palma de Mallorca, Balearic Islands
Research Site
Sabadell, Barcelona
Research Site
Santiago de Compostela, La Coru�a
Research Site
Seville, Sevilla
Research Site
Tarragona, Tarragona
Research Site
Valencia, Valencia
Research Site
Verín, Orense
Research Site
Vigo, Pontevedra
Research Site
Viladecans, Barcelona
Research Site
Zaragoza, Zaragoza
About this study
Official title: Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice
To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.
- Conditions
- GERD
- Keywords
- GERD, CLINICAL GUIDELINE, Symptoms, clinical outcome
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GERD patients | Patients with typical GERD symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic outcome of GERD management following new guideline
Measured: End of study visit 4-8w
Secondary outcomes (2)
To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome
Measured: End of study 4-8w
To evaluate the impact of GERD symptoms in HRQoL
Measured: End of study 4-8w
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startDec 2007
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javier Zapardiel, MD, Study chair, AZ SPAIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697008
- Sponsor's protocol ID
- NIS-GES-DUM-2007/3
- Acronym
- Prospect
- Status last verified
- Feb 2009
- First submitted
- 4 Jun 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice
- ClinicalTrials.gov ID
- NCT00697008
- Acronym / sponsor ID
- Prospect / NIS-GES-DUM-2007/3
- Conditions
- GERD
- Keywords
- GERD, CLINICAL GUIDELINE, Symptoms, clinical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2009 (actual)
- First posted
- 13 Jun 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.
To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GERD patients | – | –Patients with typical GERD symptoms |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with typical GERD symptoms consulting in specialized care setting and are managed following the new local GERD guidelines
Key inclusion criteria (4 listed)
- Signed informed consent
- Age above 18
- Subjects with typical GERD symptoms: predominant heartburn/regurgitation
- Naive patients or off PPI treatment in the last 2 months
Key exclusion criteria (4 listed)
- Inability to read and understand PRO instructions
- Patient not suitable to be treated following the AEG guidelines
- Concomitant treatment with NSAID, antiplatelet drugs
- Previous PPI failure
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
Symptomatic outcome of GERD management following new guideline
Time frame: End of study visit 4-8w
2 secondary outcomes
To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome
Time frame: End of study 4-8w
To evaluate the impact of GERD symptoms in HRQoL
Time frame: End of study 4-8w
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 10 Feb 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.
Javier Zapardiel, MD study chair
AZ SPAIN
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by AstraZeneca at 29 sites in Spain.
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 4 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 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. 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?
Symptomatic outcome of GERD management following new guideline (time frame: End of study visit 4-8w). 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 10 Feb 2009.