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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014