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

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ClinicalTrials.gov Identifier: NCT00750477
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : February 15, 2016
Information provided by (Responsible Party):
ESM Technologies, LLC

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 the effectiveness of NEM to placebo.

Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: NEM Dietary Supplement: Placebo Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of Natural Eggshell Membrane (NEM) in the Treatment of Pain & Stiffness Associated With Moderate Osteoarthritis of the Knee
Study Start Date : December 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: NEM Treatment
NEM, 500 mg, once daily, orally for 8 weeks
Dietary Supplement: NEM
see Treatment Arms
Other Name: Natural Eggshell Membrane

Placebo Comparator: Placebo
Placebo, 500 mg, once daily, orally for 8 weeks
Dietary Supplement: Placebo
Placebo comparator containing inactives

Primary Outcome Measures :
  1. The primary endpoint of the study was measurement of the effectiveness of NEM® in relieving pain, stiffness, and discomfort associated with moderate OA of the knee and to compare its effectiveness to placebo. [ Time Frame: 10, 30, & 60 Days ]

Secondary Outcome Measures :
  1. Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. [ Time Frame: 10, 30, & 60 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750477

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United States, Missouri
Regional Specialty Clinic
Cuba, Missouri, United States, 65453
Regional Specialty Clinic
Kirksville, Missouri, United States, 63501
St. John's Clinic
Springfield, Missouri, United States, 65807
Sponsors and Collaborators
ESM Technologies, LLC
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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
Additional Information:
Publications of Results:
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Responsible Party: ESM Technologies, LLC
ClinicalTrials.gov Identifier: NCT00750477    
Other Study ID Numbers: CLN # C0504
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ESM Technologies, LLC:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases