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

Completed

• Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Osteoarthritis

• Registration Number: NCT01519375
• Lead Sponsor: AstraZeneca

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.

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 Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Study Start: 2012-03
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-28
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported adherence to PPI treatment on actual days of NSAID treatment.	7 days

Secondary Outcome Measures

Name	Time	Method
Patient adherence to prescribed ASA treatment.	7 days
Proportion of patients with reported adherence ≤ 80%.	7 days

Trial Locations

Locations (1)

Research Site; 🇸🇪 Vannas, Sweden