Clinical trial: Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain (NCT03174145)

Eligibility criteria:
Inclusion Criteria:

          1. Men or women of at least 18 years of age.

          2. Osteoarthritis (OA) of knee or hip diagnosed since at least 6 months.

          3. Affiliated with national welfare.

          4. Reliable and willing to make themselves available for the duration of the study and
             are willing to follow study procedures.

          5. Have given written informed consent approved by the relevant Ethics Committee
             governing the study sites.

          6. 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.

          7. 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:

               1. Knee or hip pain as an average at least half of the time for the last 3 months
                  before screening visit.

               2. OA of the knee, at least 1 of the following 3 conditions:

             i. 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:

             i. 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.

             Exclusion Criteria:

          8. 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.

          9. 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).

         10. 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.

         11. Pregnant, breastfeeding, or willing to be pregnant during the study.

         12. 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.

         13. Uncontrolled epilepsy.

         14. 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).

         15. Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines,
             barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and
             phencyclidine).

         16. 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.

         17. Any close relationship with the Investigators or the Sponsor (i.e. belonging to
             immediate family or subordination link).

         18. Under legal protection, according to the national law.

         19. Having completed or withdrawn from this study or any study investigating T4P1001.

         20. 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.

         21. Have planned total knee or hip replacement intervention of the referred joint.

         22. 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).

         23. 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).

         24. 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment