Clinical trial NCT01519375: Assessment of NSAID-treated Patients Adherence to Co-prescribed Proton Pump Inhibitor (PPI)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Keywords: Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: Patient reported adherence to PPI treatment on actual days of NSAID treatment.
timeFrame: 7 days
Secondary outcomes:
measure: Proportion of patients with reported adherence ≤ 80%.
timeFrame: 7 days
measure: Patient adherence to prescribed ASA treatment.
timeFrame: 7 days
Other outcomes:
Locations:
city: Kristianstad
country: Sweden
facility: Research Site
city: Kristinehamn
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Partille
country: Sweden
facility: Research Site
city: Skanor
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Ullanger
country: Sweden
facility: Research Site
city: Vannas
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Nordics, B674:4 151 87 Södertälje, Sweden
name: Georgios Stratelis, MD, PhD
role: STUDY_DIRECTOR
affiliation: Reuma City, 111 52 Stockholm, Sweden
name: Kenneth Henriksson, MD
role: PRINCIPAL_INVESTIGATOR
References: