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

NCT02691754 | Completed

• 1 other identifier: RePara
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

Paracetamol; PPI; Opioids; NSAID; Drug Prescription

Outcome Measures

Primary Outcomes (1)

• Consumption of NSAID

  Difference in defined daily dose (DDD) per patient between the control and the intervention

  one year

Secondary Outcomes (2)

• Consumption of PPI

  one year

• Consumption of opioids

  one year

Study Arms (2)

free paracetamol

EXPERIMENTAL

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

Other: free paracetamol

standard drug prescription

NO INTERVENTION

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.

Interventions

free paracetamol OTHER

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

free paracetamol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Related Publications (1)

• 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.

  PMID: 31810456 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alessandra Ferretti, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 25, 2016
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 12, 2025

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share