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

Rheumatoid Arthritis Clinical Trial

— CONVOY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519375
• Other study ID #: NIS-RSE-ATC-2011/1
• Status: Completed
• Phase: N/A
• First received: January 23, 2012
• Last updated: May 28, 2012
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical 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. Adherence will be assessed by patient questionnaires.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported adherence to PPI treatment on actual days of NSAID treatment.		7 days	No
Secondary	Proportion of patients with reported adherence = 80%.		7 days	No
Secondary	Patient adherence to prescribed ASA treatment.		7 days	No