Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the knee.

Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly less NSAID medications for symptoms of osteoarthritis versus placebo alone.

Hypothesis 2: No significant differences will be seen for adverse events between the subjects taking Aquamin F or placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Marigot Ltd.

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.