OsteoarthritisNCT03174145
Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain
A study testing Positive behaviour, T4P1010 administration and Pharmacogenetic in people with Osteoarthritis, run by Tools4Patient at 6 sites in 3 countries.
Trial summary
The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Positive behaviour, T4P1010 administration and Pharmacogenetic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 18 Sep 2017to 24 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women of at least 18 years of age.
- Osteoarthritis (OA) of knee or hip diagnosed since at least 6 months.
- Affiliated with national welfare.
- Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have given written informed consent approved by the relevant Ethics Committee governing the study sites.
- Pain scores reported during the baseline period preceding randomization with a mean APS on the last 14 reported values before Visit 2 between 3.6 and 8.4 inclusive and to have completed at least 2/3 of each pain score in their diary between Visit 1 and Visit 2.
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- Patient with a unilateral or bilateral OA of the knee or hip diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (Altman et al., 1986) (in case of bilateral OA or OA of both knee and hip, the joint to consider should be the most affected one). The clinical diagnosis of OA will be confirmed by the ACR clinical criteria and medical imaging criteria for classification of OA of the knee or hip based upon the following criteria:
- Knee or hip pain as an average at least half of the time for the last 3 months before screening visit.
- OA of the knee, at least 1 of the following 3 conditions:
- age > 50, ii. morning stiffness <30 minutes, iii. crepitus on active motion and osteophytes.
- OA of the hip, at least 2 of the following 3 conditions:
- erythrocyte sedimentation rate < 20mm/hour, ii. femoral and/or acetabular osteophytes, iii. joint space narrowing (superior, axial, and/or medial). c. Kellgren and Lawrence grade > 1 as assessed by a recent medical imaging of the referred joint to confirm the diagnosis. If no imaging available, a new anterior- posterior view will be obtained and reviewed by Investigator or his/her delegate(s) to verify that the patient meets the disease diagnostic criteria.
Who cannot join
- Change in the " regular analgesic therapy " or introduction of a " regular analgesic therapy " (if none beforehand) for OA in the last 4 weeks prior to Visit 1 or during the study.
- Invariable pain scores reported between Visit 1 and Visit 2 (systematically the same minimum score reported all along, the same mean score reported all along and the same maximum score reported all along).
- Have initiated (or plan to initiate) a program (or modify an existing program in frequency and/or intensity) of physiotherapy or behavioral therapy such as pain self-management, hypnosis, sophrology, meditation program within 2 weeks prior to Visit 1 or during the study.
- Pregnant, breastfeeding, or willing to be pregnant during the study.
- Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
- Uncontrolled epilepsy.
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- Any current primary psychiatric condition, including depression or personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-V); personality disorders and mental retardation).
- Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine).
- Any other relevant medical disorder/acute disease state/pain condition like fibromyalgia, lumbalgia, generalized OA judged by the Investigator as likely to interfere with the trial or represent a risk for the patient.
- Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link).
- Under legal protection, according to the national law.
- Having completed or withdrawn from this study or any study investigating T4P1001.
- Patient currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.
- Have planned total knee or hip replacement intervention of the referred joint.
- Reduced mobility due to OA (use of lower extremity assistive devices other than a cane or a knee sleeve such as crutches or walker or a knee brace or a "shoe lift" in relation to OA is not allowed).
- Use or plan to use systemic corticosteroids 4 weeks prior to Visit 1 or during the study; Intra-muscular corticosteroid injections or Intra-articular injection of steroids into the referred knee/hip within 3 months before Visit 1 or during the study; Intra-articular injection of corticosteroids into any other sites than the referred knee/hip within 4 weeks prior to Visit 1 or during the study (corticosteroids in topical use are allowed).
- Have used viscosupplementation or intra articular injection of hyaluronic acid in the referred joint within 3 months prior to Visit 1 or plan to use during the study.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France3 sites
Eurofins Optimed
Gières, 38610
Hopital Saint Antoine AP-HP Rhumatologie
Paris, 75012
Hopital Cochin AP-HP Evaluation et traitement de la Douleur
Paris, 75014
United Kingdom2 sites
Mac Clinical Research
Cannock, WS11 0BN
Mac Clinical Research
Liverpool, L34 1BH
About this study
Official title: Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain of Knee or Hip
The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response
- Conditions
- Osteoarthritis
- Being tested
- Positive behaviour, T4P1010 administration, Pharmacogenetic, Questionnaires and diary completion
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive behaviourBehavioural
Information about T4P1010 treatment
T4P1010 administrationDrug
Provide treatment to be taken twice a day between Visit 2 and Visit 5 as add-on therapy to patient's regular analgesic treatment
PharmacogeneticGenetic
Blood sample of 10 millilitres maximum
Questionnaires and diary completionOther
Personality, pain and disease questionnaires completion during the study Diary completion between Visit 1 and Visit 5
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Not described Receives: Behavioral: Positive behaviour; Drug: T4P1010 administration; Genetic: Pharmacogenetic; Other: Questionnaires and diary completion |
| Control group | Sham comparator | Not described Receives: Genetic: Pharmacogenetic; Other: Questionnaires and diary completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's change from baseline of pain severity, as measured by the weekly means of the daily Average Pain Score (APS) in the last 24 hours during a 12-week treatment therapy period
11-point Numeric Rating Scale (NRS)
Measured: Time zero equals baseline (Day-28) up to Day 85
Secondary outcomes (6)
Patient's change from baseline of pain severity as measured by the weekly means of the worst pain score (WPS) in the last 24 hours
11-point NRS
Measured: Time zero equals baseline (Day-28) up to Day 85
Patient's change from baseline of pain severity as measured by the weekly means of the least pain score (LPS) in the last 24 hours
11-point NRS
Measured: Time zero equals baseline (Day-28) up to Day 85
Patient's change from baseline of condition as measured by the western Ontario and McMaster universities arthritis index (WOMAC)
Scales
Measured: From baseline (Day-28) up to Day 85
Patient's change from baseline of pain severity as measured by the brief pain inventory (BPI)
Scales
Measured: From baseline (Day-28) up to Day 85
Patient's change from baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)
11-point NRS
Measured: From baseline (Day-28) up to Day 85
Cronbach alpha assessment of MPSQ
Measured: Day 1 and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start18 Sep 2017
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tools4Patient
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvaro Pereira, Study director, Tools4Patient
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174145
- Sponsor's protocol ID
- T1010-01
- Status last verified
- Dec 2019
- First submitted
- 29 May 2017
- Last updated
- 16 Dec 2019
- 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 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain of Knee or Hip
- ClinicalTrials.gov ID
- NCT03174145
- Acronym / sponsor ID
- T1010-01
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Tools4PatientUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 2 Jun 2017 (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 purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Behavioral: Positive behaviour, Drug: T4P1010 administration, Genetic: Pharmacogenetic, Other: Questionnaires and diary completion |
| Control group | Sham comparator | Genetic: Pharmacogenetic, Other: Questionnaires and diary completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men or women of at least 18 years of age.
- Osteoarthritis (OA) of knee or hip diagnosed since at least 6 months.
- Affiliated with national welfare.
- Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have given written informed consent approved by the relevant Ethics Committee governing the study sites.
Key exclusion criteria (17 listed)
- Change in the " regular analgesic therapy " or introduction of a " regular analgesic therapy " (if none beforehand) for OA in the last 4 weeks prior to Visit 1 or during the study.
- Invariable pain scores reported between Visit 1 and Visit 2 (systematically the same minimum score reported all along, the same mean score reported all along and the same maximum score reported all along).
- Have initiated (or plan to initiate) a program (or modify an existing program in frequency and/or intensity) of physiotherapy or behavioral therapy such as pain self-management, hypnosis, sophrology, meditation program within 2 weeks prior to Visit 1 or during the study.
- Pregnant, breastfeeding, or willing to be pregnant during the study.
- Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation 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 |
|---|---|---|
| Positive behaviourInformation about T4P1010 treatment | Behavioural | Active group |
| T4P1010 administrationProvide treatment to be taken twice a day between Visit 2 and Visit 5 as add-on therapy to patient's regular analgesic treatment | Drug | Active group |
| PharmacogeneticBlood sample of 10 millilitres maximum | Genetic | Active group, Control group |
| Questionnaires and diary completionPersonality, pain and disease questionnaires completion during the study Diary completion between Visit 1 and Visit 5 | Other | Active group, Control group |
Primary outcome
Patient's change from baseline of pain severity, as measured by the weekly means of the daily Average Pain Score (APS) in the last 24 hours during a 12-week treatment therapy period
Time frame: Time zero equals baseline (Day-28) up to Day 85
11-point Numeric Rating Scale (NRS)
6 secondary outcomes
Patient's change from baseline of pain severity as measured by the weekly means of the worst pain score (WPS) in the last 24 hours
Time frame: Time zero equals baseline (Day-28) up to Day 85
Patient's change from baseline of pain severity as measured by the weekly means of the least pain score (LPS) in the last 24 hours
Time frame: Time zero equals baseline (Day-28) up to Day 85
Patient's change from baseline of condition as measured by the western Ontario and McMaster universities arthritis index (WOMAC)
Time frame: From baseline (Day-28) up to Day 85
Patient's change from baseline of pain severity as measured by the brief pain inventory (BPI)
Time frame: From baseline (Day-28) up to Day 85
Patient's change from baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)
Time frame: From baseline (Day-28) up to Day 85
Cronbach alpha assessment of MPSQ
Time frame: Day 1 and Day 85
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 16 Dec 2019.
- Clinical Trial Results published on EU Clinical Trials RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Alvaro Pereira study director
Tools4Patient
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive behaviour, T4P1010 administration and Pharmacogenetic in people with Osteoarthritis, run by Tools4Patient at 6 sites in 3 countries.
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 12 inclusion and 17 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, United Kingdom, Belgium. 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. Some participants in this study may receive a placebo. 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?
Patient's change from baseline of pain severity, as measured by the weekly means of the daily Average Pain Score (APS) in the last 24 hours during a 12-week treatment therapy period (time frame: Time zero equals baseline (Day-28) up to Day 85). 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 16 Dec 2019.