Status:
COMPLETED
Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee
Lead Sponsor:
Marigot Ltd.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
35-75 years
Phase:
PHASE1
PHASE2
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. Hypothesi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00755482
Start Date
January 1 2006
End Date
September 1 2006
Last Update
September 19 2008
Active Locations (1)
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1
Minnesota Applied Research Center
Edina, Minnesota, United States, 55345