Clinical trial: Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee (NCT00755482)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects aged 35 to 75, male or female

          -  Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee
             according to the modified criteria of the American College of Rheumatology 17,18

          -  Subjects who present with osteoarthritis of the knee as judged by symptoms and
             disabilities detectable through published, validated questionnaires or previous
             diagnosis by a physician

          -  subjects who are symptomatic with daily or near daily pain and stiffness from
             osteoarthritis

          -  subjects who are taking non-steroidal anti-inflammatory drugs (NSAIDs) prior to study
             enrollment

          -  subjects who are willing to stop NSAIDS and use acetaminophen for pain management
             during the trial

          -  subjects with screening WOMAC osteoarthritis index total score (transformed score) of
             not more than 75

          -  subjects with ability to comprehend and complete the questionnaires and forms

          -  subjects whose schedules permit clinical evaluations every four weeks

          -  subjects who are willing to stop taking calcium supplements, if any and to restrict
             consumption of high calcium food to 600mg (two dairy servings) per day

          -  subjects with a high probability of compliance with study procedures and test article
             consumption

          -  subjects willing and able to follow protocol guidelines and schedules and complete
             diaries

          -  subjects who are likely to abstain from taking unathorized supplements or
             participating in any other clinical trial or experimental treatment during this trial

          -  subjects with normal gastrointestinal digestion and absorption

        Exclusion Criteria:

          -  subjects who have a history of inflammatory arthritis, gout, pseudogout, Paget's
             disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled
             hypertension, unstable cardiovascular disease, active hepatic or renal disease, active
             cancer and/or HIV infection

          -  subjects who are non-ambulatory or bedridden due to osteoarthritis

          -  subjects who are dependent on prescription drugs to control pain

          -  subjects on any other clinical trial or experimental treatment in the past 3 months

          -  subjects who are pregnant, lactating or at risk of becoming pregnant

          -  subjects who have received : intramuscular corticosteroid injection or systemic
             corticosteroid administration within 4 weeks prior to study enrollment,
             intra-articular corticosteroid injection within 2 months prior to study enrollment or
             intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 75 Years

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? Entailment