Assessment of NSAID-treated Patients Adherence to Co-prescribed Proton Pump Inhibitor (PPI) (CONVOY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01519375
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):

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.

Condition or disease
Osteoarthritis Rheumatoid Arthritis Ankylosing Spondylitis

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 Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older

Primary Outcome Measures :
  1. Patient reported adherence to PPI treatment on actual days of NSAID treatment. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Proportion of patients with reported adherence ≤ 80%. [ Time Frame: 7 days ]
  2. Patient adherence to prescribed ASA treatment. [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01519375

Research Site
Kristianstad, Sweden
Research Site
Kristinehamn, Sweden
Research Site
Limhamn, Sweden
Research Site
Partille, Sweden
Research Site
Skanor, Sweden
Research Site
Stockholm, Sweden
Research Site
Ullanger, Sweden
Research Site
Vannas, Sweden
Sponsors and Collaborators
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

Responsible Party: AstraZeneca Identifier: NCT01519375     History of Changes
Other Study ID Numbers: NIS-RSE-ATC-2011/1
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by AstraZeneca:
Rheumatoid Arthritis
Ankylosing Spondylitis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action