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

This study has been completed.
Sponsor:
Information provided by:
Marigot Ltd.
ClinicalTrials.gov Identifier:
NCT00755482
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Aquamin F
Drug: Placebo (maltodextran)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.

Resource links provided by NLM:


Further study details as provided by Marigot Ltd.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 29
Study Start Date: January 2006
Study Completion Date: September 2006
Arms Assigned Interventions
Active Comparator: 1
Subjects were given Aquamin F
Drug: Aquamin F
Placebo Comparator: 2
Subjects were given a maltodextran placebo
Drug: Placebo (maltodextran)

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755482

Locations
United States, Minnesota
Minnesota Applied Research Center
Edina, Minnesota, United States, 55345
Sponsors and Collaborators
Marigot Ltd.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marigot Ltd
ClinicalTrials.gov Identifier: NCT00755482     History of Changes
Other Study ID Numbers: MARC005-080
Study First Received: September 18, 2008
Last Updated: September 18, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Marigot Ltd.:
Osteoarthritis
Clinical trial
Aquamin F
NSAID

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014