Ignite Creation Date:
2025-12-18 @ 7:43 AM
Ignite Modification Date:
2025-12-23 @ 9:02 PM
Study NCT ID:
NCT00750477
Status:
None
Last Update Posted:
2016-02-15 00:00:00
First Post:
2008-09-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTION
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: