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

May 28, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient reported adherence to PPI treatment on actual days of NSAID treatment.
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with reported adherence ≤ 80%.
Time Frame: 7 days
7 days
Patient adherence to prescribed ASA treatment.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 28, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RSE-ATC-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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