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

Marigot

Status and phase

Completed

Phase 2

Phase 1

Conditions

Osteoarthritis of the Knee

Treatments

Drug: Aquamin F

Drug: Placebo (maltodextran)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00755482

MARC005-080

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.