Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis
Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis
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.
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 population ages, this estimate is expected to grow rapidly. Traditional
 treatments for OA primarily attempt to address the symptoms (pain, inflammation, and
 discomfort) associated with the disease. This usually involves the use of analgesics (i.e.
 acetaminophen, tramadol), non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen,
 diclofenac), or cyclooxygenase-2-specific (COX-2) NSAIDs (i.e. celecoxib) alone or in
 combination. Steroid and hyaluronic acid injections have also been used with some success.
 Many of these treatments have shown limited effectiveness in randomized controlled clinical
 trials (RCTs). To avoid the cardiac risks and gastrointestinal issues associated with
 traditional OA treatments (particularly with long-term use), many patients have turned to
 complementary and alternative medicines (CAMs) such as dietary supplements.

 The discovery of eggshell membrane as a natural source of combined glucosamine, chondroitin,
 and hyaluronic acid has prompted the evaluation of this material as a potential treatment for
 OA. ESM Technologies, LLC (Carthage, MO) has developed methods to efficiently and effectively
 separate eggshell membrane from eggshells to create a shell-free eggshell membrane. The
 isolated membrane is then partially hydrolyzed using a proprietary process and dry-blended to
 produce 100% pure Natural Eggshell Membrane (NEM®).

 In preliminary open-label human clinical trials totaling 37 subjects with OA, oral
 supplementation with 500 mg per day of NEM® resulted in an observed decrease in pain in 7-30
 days. Therefore, an eight week randomized, multicenter, double blind, placebo controlled
 supplementation trial was conducted to evaluate the efficacy and safety of NEM® for the
 relief of the pain and stiffness associated with moderate OA of the knee - the Osteoarthritis
 Pain Treatment IncorpOrating NEM® (OPTION) trial.
Inclusion Criteria:

 -  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 Criteria:

 -  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