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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01519375
First received: January 23, 2012
Last updated: May 28, 2012
Last verified: May 2012
  Purpose

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
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Patient reported adherence to PPI treatment on actual days of NSAID treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with reported adherence ≤ 80%. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Patient adherence to prescribed ASA treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519375

Locations
Sweden
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
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01519375     History of Changes
Other Study ID Numbers: NIS-RSE-ATC-2011/1
Study First Received: January 23, 2012
Last Updated: May 28, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Anti-Inflammatory Agents, Non-Steroidal
Proton Pump Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014