Osteoarthritis of the Knee
Conditions
Keywords
Osteoarthritis, Clinical trial, Aquamin F, NSAID
Brief 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.
Interventions
DRUGAquamin F
DRUGPlacebo (maltodextran)
Sponsors
Marigot Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| DXA scans for bone mineral density | — |
| adverse events | — |
| CRP levels | — |
| Lipid profiles | — |
| the safety/toxicology measurements including a chemistry profile (including serum calcium) | — |
| complete blood counts | — |
Countries
United States
Outcome results
None listed