Overview

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.