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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02691754

Enrollment

Registered

2016-02-25

Start date

2012-11-30

Completion date

2013-11-30

Last updated

2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Paracetamol, PPI, Opioids, NSAID, Drug Prescription

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.

Interventions

OTHERfree paracetamol

General Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study Exclusion critera: \- none

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026