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Sponsored by: |
ESM Technologies, LLC |
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Information provided by: | ESM Technologies, LLC |
ClinicalTrials.gov Identifier: | NCT00750477 |
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.
Condition | Intervention |
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Osteoarthritis |
Dietary Supplement: Natural Eggshell Membrane Dietary Supplement: Placebo |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Natural Eggshell Membrane (NEM) to Relieve Pain Associated With Moderate Osteoarthritis of the Knee |
Enrollment: | 67 |
Study Start Date: | December 2004 |
Study Completion Date: | May 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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NEM Treatment: Experimental
Oral NEM® 500 mg, once daily.
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Dietary Supplement: Natural Eggshell Membrane
oral NEM® 500 mg, taken once daily for eight weeks.
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Placebo: Placebo Comparator |
Dietary Supplement: Placebo
Placebo comparator containing inactives.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
St. John's Clinic | |
Springfield, Missouri, United States, 65807 | |
Regional Specialty Clinic | |
Kirksville, Missouri, United States, 63501 | |
Regional Specialty Clinic | |
Cuba, Missouri, United States, 65453 |
Principal Investigator: | Anne Winkler, MD, PhD | St. John's Clinic - Rheumatology |
Principal Investigator: | Robert W Jackson, DO | Regional Specialty Clinic |
Study Director: | Kevin J Ruff, PhD, MBA | ESM Technologies, LLC |
Responsible Party: | ESM Technologies, LLC ( Kevin J. Ruff, Ph.D., MBA -- Technical Director ) |
Study ID Numbers: | CLN # C0504 |
Study First Received: | September 8, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00750477 |
Health Authority: | United States: Institutional Review Board |
osteoarthritis arthritis knee |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |