ComplianceGADESNCT00699725
Adherence to Gastro-protection in Non-steroidal Anti-inflammatory Drug (NSAID) Using Patients
An observational study of Compliance and Gastroprotector Therapy, run by AstraZeneca at 128 sites in Spain.
Trial summary
Prospective multicentric study to evaluate the compliance of gastroprotective treatment in NSAID patients at risk of GI complications. Secondary objectives: To identify the factors associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between compliance and NSAID-associated GI events Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compliance, Gastroprotector Therapy, Risk Factors
- How many people
- 2,000 participants
- Where
- 128 sitesSpain
- Study dates
- May 2008to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending secondary care clinics who are prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice.
Who may be able to join
- Signed informed consent
- Patients consulting to the specialized care clinics who have been prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice.
Who cannot join
- Any gastroprotective treatment prescribed for other condition than NSAID-related gastrointestinal event prevention
Trial locations and contacts
128 sites in 1 country.
128 sites in 1 country
Spain128 sites
Research Site
A Coru�a, La Coru�a
Research Site
Alacant / Alicante, Alicante
Research Site
Albacete, Albacete
Research Site
Alcalá de Henares, Madrid
Research Site
Alcoy, Alicante
Research Site
Algeciras, Cadiz
Research Site
Algemesí, Valencia
Research Site
Almería, Almeria
Research Site
Almu�ecar, Granada
Research Site
Alzira, Valencia
Research Site
Aranjuez, Madrid
Research Site
Arona, Tenerife
Research Site
Ávila, Avila
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Badajoz, Badajoz
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Badalona, Barcelona
Research Site
Barcelona, Barcelona
Research Site
Bilbao, Vizcaya
Research Site
Bre�a Alta, Tenerife
Research Site
Burela de Cabo, Lugo
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Burgos, Burgos
Research Site
Cabra, Cordoba
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Cáceres, Caceres
Research Site
Cadiz, Cadiz
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Calahorra, La Rioja
Research Site
Calatayud, Zaragoza
Research Site
Cartagena, Murcia
Research Site
Castelldefels, Barcelona
Research Site
Castellon, Castellon
Research Site
Castilleja de la Cuesta, Sevilla
Research Site
Cieza, Murcia
Research Site
Córdoba, Cordoba
Research Site
Coria, Caceres
Research Site
Cornellà de Llobregat, Barcelona
Research Site
Cuenca, Cuenca
Research Site
Don Benito, Badajoz
Research Site
El Ejido, Almeria
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El Escorial, Madrid
Research Site
El Hospitalet de Llobregat, Barcelona
Research Site
El Palmar (el Palmar), Murcia
Research Site
El Puerto de Santa María, Cadiz
Research Site
Elcano, Navarre
Research Site
Elda, Alicante
Research Site
Elx / Elche, Alicante
Research Site
Estella-Lizarra, Navarre
Research Site
Ferrol, La Coru�a
Research Site
Foz (casco Urbano), Lugo
Research Site
Fuengirola, Malaga
Research Site
Galdakao, Vizcaya
Research Site
Getafe, Madrid
Research Site
Gijón, Principality of Asturias
Research Site
Granada, Granada
Research Site
Granollers, Barcelona
Research Site
Guadalajara, Guadalajara
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Guadix, Granada
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Huelva, Huelva
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Huercal Overa, Almeria
Research Site
Jaén, Jaen
Research Site
Jerez de la Frontera, Cadiz
Research Site
La Orotava, Tenerife
Research Site
La/villajoyosa Vila Joiosa, Alicante
Research Site
Las Palmas de Gran Canaria, Las Palmas
Research Site
Leganés, Madrid
Research Site
León, Leon
Research Site
Linares, Jaen
Research Site
Lleida, Lerida
Research Site
Logro�o, La Rioja
Research Site
Lugo, Lugo
Research Site
Madrid, Madrid
Research Site
Majadahonda, Madrid
Research Site
Málaga, Malaga
Research Site
Manacor, Balearic Islands
Research Site
Manresa, Barcelona
Research Site
Marbella, Malaga
Research Site
Martorell, Barcelona
Research Site
Melilla, Melilla
Research Site
Mendaro, Guipuzcoa
Research Site
Monforte (casco Urbano), Lugo
Research Site
Móstoles, Madrid
Research Site
Motril, Granada
Research Site
Murcia, Murcia
Research Site
Murias (mieres), Principality of Asturias
Research Site
Navalmoral de la Mata, Caceres
Research Site
Oleiros (ribeira), La Coru�a
Research Site
Orihuela, Alicante
Research Site
Ourense, Orense
Research Site
Oviedo, Principality of Asturias
Research Site
Palma de Mallorca, Balearic Islands
Research Site
Pamplona, Navarre
Research Site
Plasencia, Caceres
Research Site
Pontevedra, Pontevedra
Research Site
Port de Sagunt, Valencia
Research Site
Puente-Genil, Cordoba
Research Site
Puerto del Rosario, Las Palmas
Research Site
Puertollano, Ciudad Real
Research Site
Requena, Valencia
Research Site
Ria�o (langreo), Principality of Asturias
Research Site
Sabadell, Barcelona
Research Site
San Bartolomé, Alicante
Research Site
San Cristóbal de La Laguna, Tenerife
Research Site
San Vicent del Raspeig, Alicante
Research Site
Sant Boi de Llobregat, Barcelona
Research Site
Santa Cruz de Tenerife, Tenerife
Research Site
Santiago de Compostela, La Coru�a
Research Site
Santiago de la Ribera, Murcia
Research Site
Seville, Sevilla
Research Site
Sueca, Valencia
Research Site
Talavera de la Reina, Toledo
Research Site
Tarragona, Tarragona
Research Site
Telde, Las Palmas
Research Site
Toledo, Toledo
Research Site
Tolosa, Guipuzcoa
Research Site
Torrebonica, Barcelona
Research Site
Torrelavega, Cantabria
Research Site
Torrent, Valencia
Research Site
Tudela, Navarre
Research Site
Úbeda, Jaen
Research Site
Valdepe�as, Ciudad Real
Research Site
Valencia, Valencia
Research Site
Verín, Orense
Research Site
Vigo, Pontevedra
Research Site
Viladecans, Barcelona
Research Site
Vilagarcía de Arousa, Pontevedra
Research Site
Vinaròs, Castellon
Research Site
Vitoria-Gasteiz, Alava
Research Site
Xàtiva, Valencia
Research Site
Zafra, Badajoz
Research Site
Zamora, Zamora
Research Site
Zaragoza, Zaragoza
About this study
Official title: Compliance of Gastroprotection Treatment in the Prevention of Gastrointestinal Risk in Non-Steroidal Anti-inflammatory Drug (NSAID) Using Patients
Prospective multicentric study to evaluate the compliance of gastroprotective treatment in NSAID patients at risk of GI complications. Secondary objectives: To identify the factors associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between compliance and NSAID-associated GI events
- Conditions
- Compliance, Gastroprotector Therapy, Risk Factors
- Keywords
- Compliance, gastroprotector therapy, NSAID, risk factors
- Medical subject headings
- Patient Compliance
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 |
|---|---|---|
| 1 | NSAID patients with risk factors treated with gastroprotective drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to gastroprotection treatment
Measured: End of follow-up (3-5 weeks)
Secondary outcomes (2)
Identify factors associated with treatment compliance
Measured: End of follow-up
Evaluate the relationship among GI events and treatment compliance
Measured: End of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplianceStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javier Zapardiel, Study chair, AstraZeneca Spain Medical Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699725
- Sponsor's protocol ID
- NIS-GES-DUM-2008/2
- Acronym
- GADES
- Status last verified
- Dec 2010
- First submitted
- 17 Jun 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
- Compliance of Gastroprotection Treatment in the Prevention of Gastrointestinal Risk in Non-Steroidal Anti-inflammatory Drug (NSAID) Using Patients
- ClinicalTrials.gov ID
- NCT00699725
- Acronym / sponsor ID
- GADES / NIS-GES-DUM-2008/2
- Conditions
- Compliance, Gastroprotector Therapy, Risk Factors
- Keywords
- Compliance, gastroprotector therapy, NSAID, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 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.
Prospective multicentric study to evaluate the compliance of gastroprotective treatment in NSAID patients at risk of GI complications. Secondary objectives: To identify the factors associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between compliance and NSAID-associated GI events
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –NSAID patients with risk factors treated with gastroprotective drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending secondary care clinics who are prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice.
Key inclusion criteria (2 listed)
- Signed informed consent
- Patients consulting to the specialized care clinics who have been prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice.
Key exclusion criteria (1 listed)
- Any gastroprotective treatment prescribed for other condition than NSAID-related gastrointestinal event prevention
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
Adherence to gastroprotection treatment
Time frame: End of follow-up (3-5 weeks)
2 secondary outcomes
Identify factors associated with treatment compliance
Time frame: End of follow-up
Evaluate the relationship among GI events and treatment compliance
Time frame: End of follow-up
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.
Javier Zapardiel study chair
AstraZeneca Spain Medical Dept
128 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compliance and Gastroprotector Therapy, run by AstraZeneca at 128 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 2 inclusion and 1 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 128 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?
Adherence to gastroprotection treatment (time frame: End of follow-up (3-5 weeks)). 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; AzTrials last refreshed its copy on 8 Nov 2026.