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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01519375
First received: January 23, 2012
Last updated: May 28, 2012
Last verified: May 2012

January 23, 2012
May 28, 2012
March 2012
May 2012   (final data collection date for primary outcome measure)
Patient reported adherence to PPI treatment on actual days of NSAID treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To assess patient reported adherence to PPI treatment on actual days of NSAID treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01519375 on ClinicalTrials.gov Archive Site
  • Proportion of patients with reported adherence ≤ 80%. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Patient adherence to prescribed ASA treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To assess proportion of patients with reported adherence ≤ 80%. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To assess patient adherence to prescribed ASA treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Assessment of NSAID-treated Patients Adherence to Co-prescribed Proton Pump Inhibitor (PPI)
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.

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

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
Not Provided
1
Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01519375
NIS-RSE-ATC-2011/1
No
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP