OsteoarthritisNCT02691754
Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription
A study testing free paracetamol in people with Osteoarthritis, run by Azienda USL Reggio Emilia - IRCCS.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- free paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study
Who cannot join
- none
About this study
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
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.
Read the 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
- Being tested
- free paracetamol
- Keywords
- Paracetamol, PPI, Opioids, NSAID, Drug Prescription
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free paracetamolOther
General Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital.
| Study group | Role | What they receive |
|---|---|---|
| free paracetamol | Experimental | the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of NSAID
Difference in defined daily dose (DDD) per patient between the control and the intervention
Measured: one year
Secondary outcomes (2)
Consumption of PPI
Difference in defined daily dose (DDD) per patient between the control and the intervention
Measured: one year
Consumption of opioids
Difference in defined daily dose (DDD) per patient between the control and the intervention
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alessandra Ferretti, MSc, Principal investigator, Inter-Institutional Pharmaceutical Department, Local Health Authority, Reggio Emilia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691754
- Sponsor's protocol ID
- RePara
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31810456
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02691754
- Acronym / sponsor ID
- RePara
- Conditions
- Osteoarthritis
- Keywords
- Paracetamol, PPI, Opioids, NSAID, Drug Prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| free paracetamol | Experimental | Other: free paracetamolthe General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| free paracetamolGeneral Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital. | Other | free paracetamol |
Primary outcome
Consumption of NSAID
Time frame: one year
Difference in defined daily dose (DDD) per patient between the control and the intervention
2 secondary outcomes
Consumption of PPI
Time frame: one year
Consumption of opioids
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 31810456Vicentini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Ferretti, MSc principal investigator
Inter-Institutional Pharmaceutical Department, Local Health Authority, Reggio Emilia, Italy
Questions about this trial
What is this clinical trial studying?
A study testing free paracetamol in people with Osteoarthritis, run by Azienda USL Reggio Emilia - IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of NSAID (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02691754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.