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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691754
• Other study ID #: RePara
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: February 24, 2016
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: February 2016
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of NSAID	Difference in defined daily dose (DDD) per patient between the control and the intervention	one year	No
Secondary	Consumption of PPI	Difference in defined daily dose (DDD) per patient between the control and the intervention	one year	No
Secondary	Consumption of opioids	Difference in defined daily dose (DDD) per patient between the control and the intervention	one year	Yes