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

NCT ID: NCT02691754

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-11-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

free paracetamol

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

Group Type: EXPERIMENTAL

free paracetamol

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

free paracetamol

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandra Ferretti, MSc

Role: PRINCIPAL_INVESTIGATOR

Inter-Institutional Pharmaceutical Department, Local Health Authority, Reggio Emilia, Italy

References

Vicentini M, Mancuso P, Giorgi Rossi P, Di Pede S, Pellati M, Gandolfi A, Zoboli D, Ricco D, Busani C, Ferretti A. A cluster randomized trial to measure the impact on nonsteroidal anti-inflammatory drug and proton pump inhibitor prescribing in Italy of distributing cost-free paracetamol to osteoarthritic patients. BMC Fam Pract. 2019 Dec 6;20(1):169. doi: 10.1186/s12875-019-1050-4.

Reference Type: DERIVED

PMID: 31810456 (View on PubMed)

Other Identifiers

RePara

Identifier Type: -

Identifier Source: org_study_id