OsteoarthritisCONVOYNCT01519375
Assessment of NSAID-treated Patients Adherence to Co-prescribed Proton Pump Inhibitor (PPI)
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by AstraZeneca at 8 sites in Sweden.
Trial summary
The primary objective of this cross-sectional observational real life study is to investigate the patient reported adherence to PPI, when prescribed as prevention of NSAID associated GI Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis, Rheumatoid Arthritis or Ankylosing Spondylitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- How many people
- 102 participants
- Where
- 8 sitesSweden
- Study dates
- Mar 2012to May 2012
- 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: A total of 100 patients having Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) selected from medical records at involved clinics. The investigator will select the patients in order of date by latest visits to the clinic and backwards. The patients will be selected from 4-6 involved primary care and and specialist clinics.
Who may be able to join
- Confirmed diagnosis (documented in the medical record) of OA, RA or AS
- Prescription of oral NSAID treatment for OA, RA or AS, where low dose is not sufficient
- Prescription of PPI for prevention of NSAID associated GI ulcers, with instruction to take PPI same day as when taking NSAID.
Who cannot join
- Participating in any clinical trial involving PPI or NSAID
- Patients prescribed PPI as acute treatment of GI events or symptoms within 8 weeks
- Inability to complete PROs
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites
Research Site
Kristianstad
Research Site
Kristinehamn
Research Site
Limhamn
Research Site
Partille
Research Site
Skanör
Research Site
Stockholm
Research Site
Ullanger
Research Site
Vännäs
About this study
Official title: Cross-sectional, Observational Real Life Study on NSAIDs Treated Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of Patient Adherence to PPI Treatment
The primary objective of this cross-sectional observational real life study is to investigate the patient reported adherence to PPI, when prescribed as prevention of NSAID associated GI Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis, Rheumatoid Arthritis or Ankylosing Spondylitis. Adherence will be assessed by patient questionnaires.
Read the detailed description
Cross-sectional, observational Real Life study on NSAIDs treated patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of patient adherence to PPI treatment
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing
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 | Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported adherence to PPI treatment on actual days of NSAID treatment.
Measured: 7 days
Secondary outcomes (2)
Proportion of patients with reported adherence ≤ 80%.
Measured: 7 days
Patient adherence to prescribed ASA treatment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georgios Stratelis, MD, PhD, Study director, AstraZeneca Nordics, B674:4 151 87 Södertälje, SwedenKenneth Henriksson, MD, Principal investigator, Reuma City, 111 52 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519375
- Sponsor's protocol ID
- NIS-RSE-ATC-2011/1
- Acronym
- CONVOY
- Status last verified
- May 2012
- First submitted
- 23 Jan 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional, Observational Real Life Study on NSAIDs Treated Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of Patient Adherence to PPI Treatment
- ClinicalTrials.gov ID
- NCT01519375
- Acronym / sponsor ID
- CONVOY / NIS-RSE-ATC-2011/1
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jan 2012 (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 primary objective of this cross-sectional observational real life study is to investigate the patient reported adherence to PPI, when prescribed as prevention of NSAID associated GI Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis, Rheumatoid Arthritis or Ankylosing Spondylitis. Adherence will be assessed by patient questionnaires.
Detailed description
Cross-sectional, observational Real Life study on NSAIDs treated patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of patient adherence to PPI treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 100 patients having Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) selected from medical records at involved clinics. The investigator will select the patients in order of date by latest visits to the clinic and backwards. The patients will be selected from 4-6 involved primary care and and specialist clinics.
Key inclusion criteria (3 listed)
- Confirmed diagnosis (documented in the medical record) of OA, RA or AS
- Prescription of oral NSAID treatment for OA, RA or AS, where low dose is not sufficient
- Prescription of PPI for prevention of NSAID associated GI ulcers, with instruction to take PPI same day as when taking NSAID.
Key exclusion criteria (3 listed)
- Participating in any clinical trial involving PPI or NSAID
- Patients prescribed PPI as acute treatment of GI events or symptoms within 8 weeks
- Inability to complete PROs
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
Patient reported adherence to PPI treatment on actual days of NSAID treatment.
Time frame: 7 days
2 secondary outcomes
Proportion of patients with reported adherence ≤ 80%.
Time frame: 7 days
Patient adherence to prescribed ASA treatment.
Time frame: 7 days
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 30 May 2012.
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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.
Georgios Stratelis, MD, PhD study director
AstraZeneca Nordics, B674:4 151 87 Södertälje, Sweden
Kenneth Henriksson, MD principal investigator
Reuma City, 111 52 Stockholm, Sweden
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by AstraZeneca at 8 sites in Sweden.
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 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden. 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?
Patient reported adherence to PPI treatment on actual days of NSAID treatment. (time frame: 7 days). 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 30 May 2012.