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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: free paracetamol

• Registration Number: NCT02691754
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

Brief Summary

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.

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 Timeline

• Study Start: 2012-11
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-24
• Last Update Submitted: 2016-02-24
• Study First Posted: 2016-02-25
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
free paracetamol	free paracetamol	the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital

Primary Outcome Measures

Name	Time	Method
Consumption of NSAID	one year	Difference in defined daily dose (DDD) per patient between the control and the intervention

Secondary Outcome Measures

Name	Time	Method
Consumption of PPI	one year	Difference in defined daily dose (DDD) per patient between the control and the intervention
Consumption of opioids	one year	Difference in defined daily dose (DDD) per patient between the control and the intervention