Clinical trial: Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA) (NCT01967550)

Eligibility criteria:
Inclusion Criteria:

          -  1. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to
             ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee
             originates in the knee (not referred pain from other sites, such as hip or back) and
             no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee
             OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose
             per day, for not less than 10 days out of the 14 days preceding the screening visit
             and also within the 24 hours preceding the screening visit; 5. Be able to tolerate
             rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up
             to a maximum of 6 tablets (3 grams) per day for the duration of the study

        Exclusion Criteria:

        - 1. Partial or total replacement of either knee joint, past or planned/expected during
        study duration.

        2. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis,
        hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however,
        common risk factors, such as obesity and past meniscectomy or ligament rupture and repair,
        are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid
        arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or
        laboratory values indicative of such disease with subsequent diagnosis by a physician; 4.
        Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin,
        other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene
        glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the
        rescue medication
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 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? Contradiction