Assessment of NSAID-treated Patients Adherence to Co-pres... | NCT01519375

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

NCT01519375

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

May 30, 2012Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jan 23, 2012

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2012

Last Update Posted Date

May 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient reported adherence to PPI treatment on actual days of NSAID treatment.		7 days

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with reported adherence ≤ 80%.		7 days
Patient adherence to prescribed ASA treatment.		7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georgios Stratelis, MD, PhD	AstraZeneca Nordics, B674:4 151 87 Södertälje, Sweden	Study Director
Kenneth Henriksson, MD	Reuma City, 111 52 Stockholm, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Kristianstad			Sweden
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid
D013167	Spondylitis, Ankylosing

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided