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

September 18, 2008 updated by: Marigot Ltd.

Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Edina, Minnesota, United States, 55345
        • Minnesota Applied Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Subjects were given Aquamin F
Drug: Aquamin F
Placebo Comparator: 2
Subjects were given a maltodextran placebo
Drug: Placebo (maltodextran)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
adverse events
DXA scans for bone mineral density
CRP levels
Lipid profiles
the safety/toxicology measurements including a chemistry profile (including serum calcium)
complete blood counts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marigot Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARC005-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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