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

Study Overview
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Brief Summary
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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.

Official Title
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Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Aquamin F
* Drug: Placebo (maltodextran)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subjects were given Aquamin F | Drug: Aquamin F<br> <br> |
| Placebo Comparator: 2<br>Subjects were given a maltodextran placebo | Drug: Placebo (maltodextran)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC scores (pain, stiffness, mobility, total score) |  |  | 
| 6 minute walking distances |  |  | 
| Active and Passive range of motion (goniometer measurements) |  |  | 
| NSAID usage |  |  | 
| Rescue medication (acetaminophen) usage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DXA scans for bone mineral density |  |  | 
| CRP levels |  |  | 
| Lipid profiles |  |  | 
| the safety/toxicology measurements including a chemistry profile (including serum calcium) |  |  | 
| complete blood counts |  |  | 
| adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Clinical trial, Aquamin F, NSAID