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

NCT ID: NCT01519375

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Cross-sectional, observational Real Life study on NSAIDs treated patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of patient adherence to PPI treatment

Conditions

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Osteoarthritis Rheumatoid Arthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georgios Stratelis, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca Nordics, B674:4 151 87 Södertälje, Sweden

Kenneth Henriksson, MD

Role: PRINCIPAL_INVESTIGATOR

Reuma City, 111 52 Stockholm, Sweden

Locations

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Research Site

Kristianstad, , Sweden

Site Status

Research Site

Kristinehamn, , Sweden

Site Status

Research Site

Limhamn, , Sweden

Site Status

Research Site

Partille, , Sweden

Site Status

Research Site

Skanör, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Research Site

Ullanger, , Sweden

Site Status

Research Site

Vännäs, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NIS-RSE-ATC-2011/1

Identifier Type: -

Identifier Source: org_study_id

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