Acute Pathology of the Locomotor SystemPPPCARE IINCT05905146
Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain.
A study testing personalized pharmaceutical plan in people with Acute Pathology of the Locomotor System, run by University Hospital, Rouen at 3 sites in France.
Trial summary
The aim of this study is to evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pathology of the Locomotor System
- What is being tested?
- personalized pharmaceutical plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Jan 2024to 18 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient hospitalized in the rheumatology department
- Patient with acute pain in the context of a non-cancerous, non-traumatic, high-energy musculoskeletal pathology
- Patient for whom a prescription of strong opioid derivatives is initiated in rheumatology or patient for whom a prescription of strong opioid derivatives is maintained in rheumatology if the initial prescription has a maximum duration of 30 consecutive days prior to inclusion
Who cannot join
- Patient with cancer or fibromyalgia already diagnosed at inclusion
- Patient with poor French language skills
- Taking a strong opioid treatment for more than 30 consecutive days prior to inclusion
- Person judged by the prescriber or pharmacist as not autonomous for the management of strong opioid treatment
- Patient already included in the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Lille
Lille
Chloé DELANNOY-ROUSSELIERE, Dr
- Recruiting
CHU de Nimes
Nîmes
Clarisse ROUX MARSON, Dr
- Recruiting
CHU de ROUEN
Rouen
Catherine CHENAILLER, Dr
About this study
Official title: Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. Multicenter, Randomized, Controlled Study
The aim of this study is to evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to the usual modalities in the rheumatology services concerned.
- Conditions
- Acute Pathology of the Locomotor System
- Being tested
- personalized pharmaceutical plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized pharmaceutical planOther
multi-professional intervention around strong opioid treatment with targeted pharmaceutical interview
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | benefiting from a multi-professional intervention around the strong opioid treatment with the aim of setting up a personalized pharmaceutical plan Receives: Other: personalized pharmaceutical plan |
| control group | No intervention | routine management, including medication reconciliation at entry and exit and pharmaceutical analysis of prescriptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
total duration of treatment in days with strong opioids from day of inclusion
Measured: 6 months
Secondary outcomes (3)
number of patients exceeding the optimal duration of treatment with strong opioids defined by the SFETD learned society (French Society for the Study and Treatment of Pain) (3 months)
Measured: 3 months
pain assessment (numerical scale) at first patient call after stopping strong opioids
Measured: 6 months
number of patients exceeding the optimal duration of treatment with strong opioids defined by the CLUD (Pain Control Committee) of Rouen University Hospital (28 days)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start18 Jan 2024
- Primary completion18 Jul 2028 (estimated)
- Study completion18 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pathology of the Locomotor SystemStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine CHENAILLER, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905146
- Sponsor's protocol ID
- 2020/0426/HP
- Acronym
- PPPCARE II
- Status last verified
- Feb 2026
- First submitted
- 23 May 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05905146
- Acronym / sponsor ID
- PPPCARE II / 2020/0426/HP
- Conditions
- Acute Pathology of the Locomotor System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 18 Jul 2028 (estimated)
- Study completion
- 18 Jul 2028 (estimated)
- First posted
- 15 Jun 2023 (actual)
- 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.
The aim of this study is to evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to the usual modalities in the rheumatology services concerned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Other: personalized pharmaceutical planbenefiting from a multi-professional intervention around the strong opioid treatment with the aim of setting up a personalized pharmaceutical plan |
| control group | No intervention | –routine management, including medication reconciliation at entry and exit and pharmaceutical analysis of prescriptions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient hospitalized in the rheumatology department
- Patient with acute pain in the context of a non-cancerous, non-traumatic, high-energy musculoskeletal pathology
- Patient for whom a prescription of strong opioid derivatives is initiated in rheumatology or patient for whom a prescription of strong opioid derivatives is maintained in rheumatology if the initial prescription has a maximum duration of 30 consecutive days prior to inclusion
Key exclusion criteria (5 listed)
- Patient with cancer or fibromyalgia already diagnosed at inclusion
- Patient with poor French language skills
- Taking a strong opioid treatment for more than 30 consecutive days prior to inclusion
- Person judged by the prescriber or pharmacist as not autonomous for the management of strong opioid treatment
- Patient already included in the study
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 |
|---|---|---|
| personalized pharmaceutical planmulti-professional intervention around strong opioid treatment with targeted pharmaceutical interview | Other | interventional group |
Primary outcome
total duration of treatment in days with strong opioids from day of inclusion
Time frame: 6 months
3 secondary outcomes
number of patients exceeding the optimal duration of treatment with strong opioids defined by the SFETD learned society (French Society for the Study and Treatment of Pain) (3 months)
Time frame: 3 months
pain assessment (numerical scale) at first patient call after stopping strong opioids
Time frame: 6 months
number of patients exceeding the optimal duration of treatment with strong opioids defined by the CLUD (Pain Control Committee) of Rouen University Hospital (28 days)
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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.
Catherine CHENAILLER principal investigator
University Hospital, Rouen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized pharmaceutical plan in people with Acute Pathology of the Locomotor System, run by University Hospital, Rouen at 3 sites in France.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine CHENAILLER (+3323288 ext. 82.07, catherine.chenailler@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total duration of treatment in days with strong opioids from day of inclusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.