Clinical trial: Efficacy of Myalgesin™ to Support Joint Function in Patients With Knee Osteoarthritis (NCT00577330)

Eligibility criteria:
Inclusion Criteria:

          -  Men and women age 50-years or older.

          -  Patients with symptomatic osteoarthritis of the knees as defined by the American
             College of Rheumatology criteria(traditional format).

          -  At least moderate pain in the knee (rated at 40 or greater by the subject on a visual
             analogue scale) for most days during the last month.

          -  Use of analgesic or anti-inflammatory agents for control of pain for at least 1 month.

          -  Baseline functional capacity class 1 to 3, in which class 1 is complete ability to
             carry out usual activities without handicap,class 2 is ability to adequately conduct
             usual activities despite handicap of discomfort or limited mobility of one or more
             joints,and class 3 is limited ability to carry out usual activities. (American
             Rheumatism Association functional class)

          -  Documented radiographic changes of osteoarthritis on a previous knee radiograph
             (Kellgren-Lawrence grade of 2 or more).

        Exclusion Criteria:

          -  Age <50-years.

          -  Body mass index (BMI) equal to or greater than 35 kg/m2.

          -  Baseline functional class 4 with the subject bedridden or confined to wheelchair,
             largely or wholly incapacitated and capable of little or no self-care. (American
             Rheumatism Association functional class)

          -  Inflammatory arthritis, gout, pseudogout, or Paget's disease.

          -  Presence of chronic pain syndromes, such as fibromyalgia or reflex sympathetic
             dystrophy, that may interfere with the assessment of joint symptomatology.

          -  Severe bursitis of the knee.

          -  History of acute joint trauma within 30 days of study entry.

          -  Complete loss of articular cartilage.

          -  History of total knee replacement.

          -  Intra-articular/intramuscular corticosteroids within 30 days of study entry.

          -  Intra-articular hyaluronan and hyalans within 30 days of study entry.

          -  History of gastrointestinal bleeding within 1 year of study entry.

          -  Active peptic ulcer disease, gastroesophageal reflux disease, or inflammatory bowel
             disease.

          -  Gastrointestinal tract ulceration within 30 days of study entry.

          -  Severe renal dysfunction defined as a serum creatinine greater than 2 mg/dL.

          -  Clinically significant liver disease including an aspartate aminotransferase or
             alanine aminotransferase >2 times the upper limit of normal.

          -  Unwillingness or inability to abstain from ethanol for the study duration.

          -  Significant bleeding disorder.

          -  History of gastric or duodenal surgery.

          -  Warfarin use.

          -  Sensitivity to acetaminophen or to any of the components of Myalgesin™.

          -  Pregnancy.

          -  Any serious medical, social or psychological condition that, in the opinion of the
             Principal Investigator, would disqualify a subject from participation.
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