Clinical trial: NGA-01 Gel for the Treatment of Osteoarthritis With Joint Pain (NCT04612283)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects having at least one or more sign and symptoms of Osteoarthritis like Pain in
             joints (at Knee, Hip, Ankle, Elbow and Shoulder), stiffness, difficulty in flexion and
             extension, crepitus, swelling etc for more than 3 months prior to the study.

          -  Pain score of at least 4 cm on a 10-cm linear visual analogue scale.

          -  Are free of any systemic or dermatologic disorder, which, in the opinion of the
             investigator, will interfere with the study results or increase the risk of adverse
             events.

          -  Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation
             (natural or artificial) for the duration of the study.

          -  Are willing to refrain from using any lotions, gel, balm, moisturizer, cleansers,
             cosmetics or creams, other than those issued as part of the study, on the treatment
             areas during the treatment period.

          -  If female of childbearing potential, must be willing to practice an acceptable form of
             birth control for the duration of the study.

          -  Are able to give written informed consent in a manner approved by the Institutional
             Ethics Committee and comply with the requirements of the study.

          -  Are willing to avoid participation in any other interventional clinical trial for the
             duration of this study.

        Exclusion Criteria:

          -  Are pregnant, breast-feeding, or planning to become pregnant during the study.

          -  Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis,
             Gouty Arthritis.

          -  Complications of OA, like Pseudogout, Spontaneous osteonecrosis of the knee, Ruptured
             Baker cyst, Bursitis, Anserine bursitis (knee)interfere with the disease and
             treatment.

          -  Severe Stomach infection.

          -  Severely traumatised and/or very severe or mucosal inflammation

          -  Peritonsillar abscess

          -  Long term use (≥ 3 times per week within the last month or regular intake within the
             last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow
             release analgesic intake including Non Steroidal Anti-Inflammatory Drugs
             (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)

          -  Any anti-inflammatory drugs intake by systemic route within 12 hours before
             randomization

          -  Any paracetamol intake within 6 hours before randomisation

          -  Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6
             hours before randomisation

          -  Heavy smokers (>10 cigarettes/day)

          -  Have open sores or open lesions in the treatment area(s).

          -  Have any condition that, in the opinion of the investigator, would confound the safety
             and/or efficacy assessments of plaque Arthritis.

          -  Have participated in any interventional clinical trial in the previous 30 days.

          -  Have a known sensitivity to any of the constituents of the test product

          -  Have used, are using, or are planning to use immunosuppressive or immunomodulatory
             medication (i.e., biologics), including oral or parenteral corticosteroids.

          -  Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or
             illegal drug/substance abuse in the past 2 years.

          -  Plan to seek alternative treatment of any kind for their Arthritis, in the eligible
             treatment areas or otherwise, during the trial period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 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