Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription

February 24, 2016 updated by: Azienda Unità Sanitaria Locale Reggio Emilia

A Cluster Randomised Trial to Measure the Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription

Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but it is not included in list of drugs than can be prescribed in charge of National Health System by General Practitioners. The hypothesis is that removing this economical barrier the investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors (PPI), often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary outcome, opioids use was also monitored to see.

Aim of the study is to test if allowing prescription of free paracetamol decreases the prescription of NSAID in osteoarthritic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial was conducted in two primary care units of the province of Reggio Emilia. The units have about 34.000 inhabitants. In this units 16 General Practitioners are active, the average beneficiaries per General Practitioner are 1500, about one fourth over 65 years old.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: free paracetamol
the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital
Other: free paracetamol
General Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital.
No Intervention: standard drug prescription

Paracetamol is not included in the list of drugs than can be prescribed in charge of National Health System by General Practitioners.

The General Practitioners can prescribe other drugs or recommend paracetamol payed by the patient (out of pocket) at the chemistry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of NSAID
Time Frame: one year
Difference in defined daily dose (DDD) per patient between the control and the intervention
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of PPI
Time Frame: one year
Difference in defined daily dose (DDD) per patient between the control and the intervention
one year
Consumption of opioids
Time Frame: one year
Difference in defined daily dose (DDD) per patient between the control and the intervention
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

Investigators

  • Principal Investigator: Alessandra Ferretti, MSc, Inter-Institutional Pharmaceutical Department, Local Health Authority, Reggio Emilia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RePara

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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