Assessment of NSAID-treated Patients Adherence to Co-prescribed Proton Pump Inhibitor (PPI)
CONVOY
Cross-sectional, Observational Real Life Study on NSAIDs Treated Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of Patient Adherence to PPI Treatment
1 other identifier
observational
102
1 country
8
Brief 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. Adherence will be assessed by patient questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2012
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
January 26, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 30, 2012
May 1, 2012
2 months
January 23, 2012
May 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient reported adherence to PPI treatment on actual days of NSAID treatment.
7 days
Secondary Outcomes (2)
Proportion of patients with reported adherence ≤ 80%.
7 days
Patient adherence to prescribed ASA treatment.
7 days
Study Arms (1)
1
Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Kristianstad, Sweden
Research Site
Kristinehamn, Sweden
Research Site
Limhamn, Sweden
Research Site
Partille, Sweden
Research Site
Skanör, Sweden
Research Site
Stockholm, Sweden
Research Site
Ullanger, Sweden
Research Site
Vännäs, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Georgios Stratelis, MD, PhD
AstraZeneca Nordics, B674:4 151 87 Södertälje, Sweden
- PRINCIPAL INVESTIGATOR
Kenneth Henriksson, MD
Reuma City, 111 52 Stockholm, Sweden
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
January 26, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 30, 2012
Record last verified: 2012-05