Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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 the effectiveness of NEM to placebo.

Key facts

Study ID

NCT00750477

Run by

ESM Technologies, LLC

People needed

67

Starts

2004-12-01

Expected to finish

2006-05-01

Last updated by the study team

2016-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Regional Specialty Clinic — Cuba, Missouri, United States
• Regional Specialty Clinic — Kirksville, Missouri, United States
• St. John's Clinic — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.