Clinical trial NCT00750477: Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
arthritis
knee
eggshell
membrane
OPTION
Lead sponsor: ESM Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 10, 30, & 60 Days
Secondary outcomes:
measure: Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
timeFrame: 10, 30, & 60 Days
Other outcomes:
Locations:
city: Cuba
country: United States
facility: Regional Specialty Clinic
state: Missouri
city: Kirksville
country: United States
facility: Regional Specialty Clinic
state: Missouri
city: Springfield
country: United States
facility: St. John's Clinic
state: Missouri
Study officials:
affiliation: St. John's Clinic - Rheumatology
name: Anne Winkler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Specialty Clinic
name: Robert W Jackson, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: ESM Technologies, LLC
name: Kevin J Ruff, PhD, MBA
role: STUDY_DIRECTOR
References:
citation: Ruff KJ, Winkler A, Jackson RW, DeVore DP, Ritz BW. Eggshell membrane in the treatment of pain and stiffness from osteoarthritis of the knee: a randomized, multicenter, double-blind, placebo-controlled clinical study. Clin Rheumatol. 2009 Aug;28(8):907-14. doi: 10.1007/s10067-009-1173-4. Epub 2009 Apr 2.