Clinical trial: Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA (NCT02079727)

Eligibility criteria:
Inclusion Criteria:

          -  Outpatients of either sex, aged ≥50 years

          -  Patients affected by primary knee osteoarthritis of the medial or lateral
             femoro-tibial compartment

          -  Diagnosis according to the American College of Rheumatology (ACR) criteria

          -  Kellgren & Lawrence grade I-III

          -  Knee osteoarthritis evolving for more than 6 months

          -  Patients suffering from regular pain and functional disorders from at least 3 months

          -  Accomplishing a score ≥ 7 of Lequesne's index for the knee osteoarthritis

          -  Assessing pain on Huskisson's VAS ≥ 50 mm

          -  With radiography dated less than six months showing a remaining articular joint space

          -  Without such an axial disorder to justify an osteotomy

          -  Women taking contraceptive measures if not in menopause

          -  Women having negative pregnancy test

          -  Patients able to understand and follow the study protocol

          -  Patients who have signed the written informed consent for their participation in the
             clinical trial

        Exclusion Criteria:

          -  With a history of heart attack, ischemic heart disease or cerebrovascular disease
             (including transient ischemic attacks)

          -  Having or have had peripheral arterial disease or past surgery orf peripheral arteries

          -  With a history or currently significat coagulation defect or/and blood dyscrasia

          -  With high risk of cardiovascular events

          -  With any acute or chronic infections requiring antimicrobial therapy or serious viral
             (e.g., hepatitis, HIV positivity) or fungal infections

          -  With a history of recurrent gastrointestinal ulceration or active inflammatory bowel
             diseases (e.g., Crohn's disease or ulcerative colitis)

          -  Having been diagnosed as having or have been treated for oesophageal, gastric, pyloric
             channel, or duodenal ulceration within 30 days prior to receiving the first dose of
             study medication

          -  Having severe liver or kidney disease

          -  With allergy to Celebrex or any of the other ingredients of Celebrex

          -  Having had an allergic reaction to sulphonamides

          -  Having had, as a result of intake of acetylsalicylic acid or other NSAIDs, asthma,
             nose polyps, severe nose congestion, or an allergic reaction such as itchy skin rash,
             swelling of the face, lips, tongue or throat, breathing difficulties or wheezing

          -  Presenting lactose intolerance

          -  Mild or not symptomatic knee osteoarthritis : < 7 of Lequesne's index,

          -  Pain on Huskisson's VAS (Visual Analogic Scale) < 50 mm

          -  Predominantly femoro-patellar osteoarthritis

          -  Destructive osteoarthritis of the knee justifying a surgery in the following 6 months

          -  Osteoarthritis with hydrarthrosis requiring a puncture or an infiltration

          -  Important genu varum or valgus >8° (physiological angle including)

          -  Kellgren & Lawrence grade IV

          -  Knee joint surgery in the last 3 months (e.g. chondroscopy, arthroscopy)

          -  Viscosupplementation, tidal lavage in the last 6 months

          -  Arthritis and metabolic arthropathies, Paget's illness

          -  Having consumed: basic treatment of arthritis with SYSADOA, symptomatic slow acting
             drugs for osteoarthrithis (chondroitin sulphates, glucosamine sulphates, diacerhein,
             hyaluronic acid and food supplement for joint care) in the last 3 months; treatment
             with corticoids, by any administration route during the last month; any medication
             having an influence on pain:

          -  NSAIDs (nonsteroidal anti-inflammatory drugs) in the 5 days preceding the inclusion
             (wash-out period considering 5 half-lives of the drug)

          -  hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days
             before inclusion

          -  paracetamol in the 10 hours preceding the inclusion

          -  Foreseen physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture)
             in the next six months (study period)

          -  Presenting psychiatric illness hindering the protocol complaince, alcoholism, ongoing
             or < 1 year drug dependency

          -  Pregnant or likely to become it during clinical trial or lactating

          -  Women having positive pregnancy test

          -  Having participated in other clinical trials in the month preceding the clinical
             trial.
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 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 0