OsteoarthritisOPTIONNCT00750477
Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis
A study testing NEM in people with Osteoarthritis, run by ESM Technologies, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- NEM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2004to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Regional Specialty Clinic
Cuba, Missouri, 65453
Regional Specialty Clinic
Kirksville, Missouri, 63501
St. John's Clinic
Springfield, Missouri, 65807
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- NEM, Placebo
- Keywords
- osteoarthritis, arthritis, knee, eggshell, membrane, OPTION
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMDietary supplement
Also called Natural Eggshell Membrane
see Treatment Arms
PlaceboDietary supplement
Placebo comparator containing inactives
| Study group | Role | What they receive |
|---|---|---|
| NEM Treatment | Experimental | NEM, 500 mg, once daily, orally for 8 weeks Receives: Dietary Supplement: NEM |
| Placebo | Placebo comparator | Placebo, 500 mg, once daily, orally for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10, 30, & 60 Days
Secondary outcomes (1)
Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
Measured: 10, 30, & 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startDec 2004
- Primary completionJan 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESM Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Winkler, MD, PhD, Principal investigator, St. John's Clinic - RheumatologyRobert W Jackson, DO, Principal investigator, Regional Specialty ClinicKevin J Ruff, PhD, MBA, Study director, ESM Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750477
- Sponsor's protocol ID
- CLN # C0504
- Acronym
- OPTION
- Status last verified
- Feb 2016
- First submitted
- 8 Sep 2008
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19340512
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00750477
- Acronym / sponsor ID
- OPTION / CLN # C0504
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, arthritis, knee, eggshell, membrane, OPTION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ESM Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEM Treatment | Experimental | Dietary Supplement: NEMNEM, 500 mg, once daily, orally for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, 500 mg, once daily, orally for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEMAlso: Natural Eggshell Membranesee Treatment Arms | Dietary supplement | NEM Treatment |
| PlaceboPlacebo comparator containing inactives | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
Time frame: 10, 30, & 60 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Results publication: PubMed 19340512Ruff 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.
- Digital Object Identifier link to published study in Clinical Rheumatology.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Winkler, MD, PhD principal investigator
St. John's Clinic - Rheumatology
Robert W Jackson, DO principal investigator
Regional Specialty Clinic
Kevin J Ruff, PhD, MBA study director
ESM Technologies, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEM in people with Osteoarthritis, run by ESM Technologies, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 10, 30, & 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.