Clinical trial: To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint. (NCT04833946)

Eligibility criteria:
Inclusion Criteria:

          1. Male and female Patients aged ≥50 and ≤85 years.

          2. Patients with a history of clinically symptomatic OA of the knee for ≥ 6 months.

          3. Index knee joint pain rated ≥60 mm on a 100 point Pain Visual Analogue Scale (VAS).

          4. Patient must have a diagnosis of idiopathic OA according to the American College of
             Rheumatology clinical and radiographic criteria with knee pain, osteophytes, and
             fulfilment of at least 2 of the 3 criteria:

               -  Age of ≥50 years Stiffness lasting <30 minutes after getting up in the morning

               -  Crepitus

          5. Radiographic evidence of grade III knee OA based on the Kellgren and Lawrence (KL)
             radiographic entry criteria for OA.

             - Grade III: Anteroposterior weight-bearing knee radiograph demonstrates definite
             joint space narrowing, multiple osteophyte formations, some sclerosis, and possible
             deformity of bony ends.

          6. Patients with normal liver & renal function defined as:

               -  Serum Alkaline phosphatase levels up to 1.5 of ULN (Upper Limit of Normal).

               -  Serum AST and ALT levels up to 2.5 of ULN.

               -  Serum creatinine levels up to 1.5 of ULN.

               -  Blood Urea Nitrogen levels up to 1.5 of ULN.

          7. Female Patients must not be of childbearing potential (defined as postmenopausal for
             at least 1 year or surgically sterile [bilateral tubal ligation, bilateral
             oophorectomy, or hysterectomy])

          8. Patients must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin,
             acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy,
             acupuncture) starting from the screening visit until completing participation in the
             study.

          9. Abstinence from any home-based remedies or any other form of topical products intended
             for knee joint pain relief for the entire study duration.

         10. Patient must be willing to avoid unaccustomed physical activity (eg, starting a new
             weight lifting routine) for the duration of the study starting from the screening
             visit.

         11. Ability to read and provide written, personally signed, and dated informed consent to
             participate in the study.

         12. An understanding, ability, and willingness to fully comply with study procedures and
             restrictions.

        Exclusion Criteria:

          1. Patients who have any contraindications to MRI, such as, but not limit to:A metal
             device affected by MRI (e.g. any type of electronic, mechanical, or magnetic implant;
             cardiac pacemaker; aneurysm clip(s); implanted cardiac defibrillator); - Have history
             of orbit trauma by a potential ferromagnetic foreign body (metal slivers, metal
             shavings, other metal objects) for which they sought medical attention; - Have
             claustrophobia; - Have difficulty fitting into the MRI knee coil due to greater than
             normal thigh diameter.

          2. Any other lower limb dis-functionality of lower limb other than the knee that, in the
             opinion of the Investigator, could interfere with pain and functional assessments
             related to the knee.

          3. Patients who has a history of total or partial knee replacement, arthroplasty, or
             other knee surgery on either knee.

          4. Patients who has had significant injury, as judged by the Investigator, involving the
             target knee within the 6 months before screening.

          5. Patients who has used opiates or corticosteroids within 30 days before screening for
             the target knee or who requires treatment with chronic opiates or corticosteroids or
             had intra articular injections of corticosteroids, hyaluronic acid, or visco
             supplements to a knee to be treated within the 3 months before Screening.

          6. Patients who has a history of significant hypersensitivity, intolerance, or allergy to
             ibuprofen, any NSAIDs, aspirin, or acetaminophen.

          7. Known sensitivity to the investigational product or any excipients of the drug
             product.

          8. Patients who has a history of chronic inflammatory disease (such as rheumatoid
             arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions
             that may affect the target joint or the functional and pain assessments (eg,
             osteonecrosis, chondrocalcinosis).

          9. Patients has any clinically significant unstable cardiac, respiratory, neurological,
             immunological, hematological, or renal disease, or any other condition that, in the
             investigator's opinion, could compromise the Patient's welfare, ability to communicate
             with the study staff, or otherwise contraindicate study participation.

         10. Patients has any other clinically significant laboratory finding at screening that in
             the investigator's opinion contraindicates study participation.

         11. Presence of uncontrolled hypertension (Defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm
             Hg).

         12. Uncontrolled diabetes defined as fasting blood glucose (FBG) > 125 mg/dL.

         13. Patients with heavy alcohol consumption, defined as - For men: More than 14 standard
             alcoholic drink (SAD)/week or more than 4 SAD in a day. - For women: More than 7
             SAD/week or more than 3 SAD in a day.

             (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which
             is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9%
             alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry
             or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).

         14. Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a
             2-hour time frame.

         15. Individuals having a history (in past 2 years) of smoking or currently smoking or
             using any form of smokeless tobacco.

         16. Patients without access to telephone and/or ability to gain technology access.

         17. Patients who participated in another human trial within last 90 days prior to
             screening.

         18. Any condition that could, in the opinion of the investigator, preclude the Patient's
             ability to successfully and safely complete the study or that may confound study
             outcomes.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 85 Years

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