Status:
COMPLETED
Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis
Lead Sponsor:
ESM Technologies, LLC
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness of Natural Eggshell Membrane (NEM) for the relief of pain and stiffness associated with moderate osteoarthritis of the knee and to compare th...
Detailed Description
Osteoarthritis (OA) is the most prevalent form of arthritis and is estimated to affect nearly 27 million adults in the U.S., with one third of those 65 and older having been diagnosed with OA. As the ...
Eligibility Criteria
Inclusion
- known symptomatic osteoarthritis of the knee
- patients must have been diagnosed with functional Grades I-III of osteoarthritis according to the modified criteria of the American College of Rheumatology
- must also have had persistent knee pain associated with osteoarthritis with a baseline score of at least 30 mm on the Patient's Assessment of Arthritis Pain - Visual Analog Scale
- required to suspend all current pain relief medications. Subjects that were currently taking analgesic medications were eligible to participate in the study following a 14 day washout period for NSAIDs, a 7 day washout for narcotics, and a 90 day washout for injected steroids. Subjects currently taking glucosamine, chondroitin sulfate or MSM were only eligible after a 3-month washout period.
Exclusion
- are currently receiving remission-inducing drugs such as methotrexate or immunosuppressive medications or had received them within the past 3 months
- had a confounding inflammatory disease or condition (rheumatoid arthritis, gout, pseudo gout, Paget's disease, chronic pain syndrome, etc.) that would interfere with assessment of pain associated with the index knee
- body weight 250 pounds or greater
- having a known allergy to eggs or egg products
- pregnant or breastfeeding women
- Subjects previously enrolled in a study to evaluate pain relief within the past 6 months or currently involved in any other research study involving an investigational product (drug, device, or biologic) or a new application of an approved product, within 30 days of screening
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00750477
Start Date
December 1 2004
End Date
May 1 2006
Last Update
February 15 2016
Active Locations (3)
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1
Regional Specialty Clinic
Cuba, Missouri, United States, 65453
2
Regional Specialty Clinic
Kirksville, Missouri, United States, 63501
3
St. John's Clinic
Springfield, Missouri, United States, 65807