Osteoarthritis, KneeNCT02291757
Efficacy and Safety of NEM® Brand Eggshell Membrane in Patients With Grade 2/3 Knee Osteoarthritis
A study testing NEM brand eggshell membrane in people with Osteoarthritis, Knee, run by Generica Pharmaceuticals at 8 sites in Turkey (Türkiye).
Trial summary
This study was designed to evaluate the efficacy and safety of NEM® brand eggshell membrane in patients with grades 2 and 3 knee osteoarthritis (OA) having significant joint pain and stiffness, in a large, multi-center clinical trial. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- NEM brand eggshell membrane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- Oct 2013to May 2015
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 40 years of age or older.
- Subjects must be applied to the Physical Treatment and Rehabilitation clinics with knee pain complaints and the subjects must be diagnosed as knee osteoarthritis exactly with routine laboratory and X-RAY degeneration detection methods. Subjects must have 2nd or 3rd grade knee osteoarthritis diagnose according to the Kellgren Lawrance criteria as a result of the knee graph determined with Anteroposterior (AP) graph method while standing on referencing American College of Rheumatology (ACR) or The European Leauge Aganist Rheumatism (EULAR) 2010.
- Male or female subjects can be included in the study.
- Subject must not have been diagnosed with a joint or connective tissue (JCT) disease other than osteoarthritis (i.e. rheumatoid arthritis, gout, pseudo gout, paget.) by a licensed physician prior to enrollment evaluation.
- Subject must have mild to moderate persistent joint pain lasting for at least 3 months with a score of at least 15 mm on a Patient's Assessment of Joint pain - WOMAC Osteoarthitiris Index and Visual Analog Scale (VAS).
- Subjects must have disease complaints for at least 1-5 years.
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- Subject must diagnosed with 2nd or 3rd grade knee osteoarthritis according to Kellgren Lawrance criteria.
- Body mess index of the subjects must be 35 or below.
- Subject must be available for and willing to attend all evaluation visits.
- Subject must be able and willing to give informed consent.
- Subject must be willing to take NEM® or placebo and to stop taking all prescription medications, over-the-counter (OTC) treatments, or dietary supplements that might be considered analgesic or anti-inflammatory (i.e. Non Steroidal Anti Imflammatory Drugs - NSAIDs) or that might confound the study results, as judged by the clinical investigator. Examples of these types of medications are: aspirin (excluding 300 mg and over),paracetamol, ibuprofen, naproxen, oxycodone, propoxyphene, diclofenac, celecoxib, glucosamine, chondroitin, MSM (Methyl Sulfonylmethane) , white willow bark, turmeric or curcumin, Boswellia, etc.
- Washout Periods: Subjects are eligible to participate in the study following a 7-day washout period for narcotics, a 14-day washout period for analgesics \& NSAIDs, and a 90-day washout period for steroids or JCT dietary supplements (i.e. glucosamine, chondroitin, MSM, etc.)
- Subjects must be willing to use only paracetamol as rescue pain medication, provided as part of the study.
Who cannot join
- Subject has Grade IV (4) osteoarthritis (Kellgren-Lawrence) as judged by the clinical investigator
- Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, Tumor Necrosis Factor (TNF) alpha blockers, steroids and glucosamine condtroitin) or any investigational drug.
- Subject has been diagnosed with any confounding inflammatory disease or condition that would interfere with the assessment of the study treatment, as judged by the clinical investigator (i.e. pseudo gout, Paget's disease, chronic pain syndrome etc.).
- Subject has been enrolled in a study to evaluate a JCT treatment in the past 6 months.
- Subject has known allergy to eggs or egg products. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study.
- Such sensitivity may be realized as a reaction to inoculations wherein the inoculate is derived from or contains egg components (i.e., influenza vaccine).
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- Subject body mess index greater than 35.
- Pregnant and breastfeeding women.
- Subject has severe persistent joint pain lasting for at least 3 months with a score of 80 mm or more on a Patient's Assessment of Joint pain WOMAC OA Index and Visual Analog Scale (VAS).
- Subject is unwilling to forgo use of prescription, over-the-counter (OTC) treatments, and/or dietary supplements for the duration of the study.
- Subject is 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
8 sites in 1 country.
8 sites in 1 country
Turkey (Türkiye)8 sites
Akdeniz University School of Medicine
Antalya
Adnan Menderes University School of Medicine
Aydin
Uludağ University School of Medicine
Bursa
Atatürk University School of Medicine
Erzurum
İstanbul University Cerrahpaşa School of Medicine
Istanbul
İstanbul University İstanbul School of Medicine
Istanbul
Marmara University School of Medicine
Istanbul
Ordu University School of Medicine
Ordu
About this study
Official title: Evaluation of the Efficacy and Safety of NEM® Brand Eggshell Membrane in Patients With Grade 2/3 Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Placebo-controlled, Single-crossover Study
This study was designed to evaluate the efficacy and safety of NEM® brand eggshell membrane in patients with grades 2 and 3 knee osteoarthritis (OA) having significant joint pain and stiffness, in a large, multi-center clinical trial.
Read the detailed description
This study was designed to evaluate the efficacy and safety of NEM® brand eggshell membrane in patients with grades 2 and 3 knee osteoarthritis (OA) having significant joint pain and stiffness, in a large, multi-center clinical trial. Improvement in joint pain and stiffness, if any, will be evaluated using the Western Ontario and McMaster Universities osteoarthritis index ((WOMAC; v LK3.1: Turkish language translation). Improvement in knee range of motion (ROM), if any, will be measured by goniometer.
- Conditions
- Osteoarthritis, Knee
- Being tested
- NEM brand eggshell membrane, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEM brand eggshell membraneDietary supplement
Also called Natural Eggshell Membrane
NEM 500 mg, once daily, p.o.
PlaceboDietary supplement
Placebo, 500 mg, once daily, p.o.
| Study group | Role | What they receive |
|---|---|---|
| NEM brand eggshell membrane | Active comparator | Subjects will be given enough treatment capsules or placebo capsules for 30-days after initial assessment, covering both the 7- and 30-day follow-up visits. Receives: Dietary Supplement: NEM brand eggshell membrane |
| Placebo | Placebo comparator | Subjects will be given enough treatment capsules or placebo capsules for 30-days after initial assessment, covering both the 7- and 30-day follow-up visits. At the 30-day evaluation, patients in the placebo group will cross over to the treatment group for the remainder of the study and all patients will be given a 60-day supply of treatment capsules covering the 90-day follow-up visit. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total WOMAC Score from Baseline
Clinical assessment of OA will be done using the Western Ontario and McMaster Universities Osteoarthritis Index ((WOMAC; v LK3.1: Turkish language translation) in the treatment group versus placebo. Possible score zero up to 96, with lower scores indicating better outcomes.
Measured: 30 days
Secondary outcomes (2)
Change in Range of Motion (ROM) from Baseline as measured by goniometer
Measurement of joint range of motion by goniometer in the treatment group versus placebo.
Measured: 30 days
Safety Evaluations as measured by number of Participants with Adverse Event
The evaluation of safety and tolerability in all study group and for treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Crossover
- Model description
- Single-crossover at 4 weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Generica Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optimum Contract Research Organisation
- Responsible party
- Sponsor
- Investigators
- Meltem Çakmakgil, Dr., Study director, Generica Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291757
- Sponsor's protocol ID
- U1111-1151-1846
- Status last verified
- Aug 2018
- First submitted
- 3 Nov 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of NEM® Brand Eggshell Membrane in Patients With Grade 2/3 Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Placebo-controlled, Single-crossover Study
- ClinicalTrials.gov ID
- NCT02291757
- Acronym / sponsor ID
- U1111-1151-1846
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Generica PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Optimum Contract Research Organisation
- Study start
- Oct 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Nov 2014 (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.
This study was designed to evaluate the efficacy and safety of NEM® brand eggshell membrane in patients with grades 2 and 3 knee osteoarthritis (OA) having significant joint pain and stiffness, in a large, multi-center clinical trial.
Detailed description
This study was designed to evaluate the efficacy and safety of NEM® brand eggshell membrane in patients with grades 2 and 3 knee osteoarthritis (OA) having significant joint pain and stiffness, in a large, multi-center clinical trial. Improvement in joint pain and stiffness, if any, will be evaluated using the Western Ontario and McMaster Universities osteoarthritis index ((WOMAC; v LK3.1: Turkish language translation). Improvement in knee range of motion (ROM), if any, will be measured by goniometer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-crossover at 4 weeks
| Arm | Type | Receives |
|---|---|---|
| NEM brand eggshell membrane | Active comparator | Dietary Supplement: NEM brand eggshell membraneSubjects will be given enough treatment capsules or placebo capsules for 30-days after initial assessment, covering both the 7- and 30-day follow-up visits. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects will be given enough treatment capsules or placebo capsules for 30-days after initial assessment, covering both the 7- and 30-day follow-up visits. At the 30-day evaluation, patients in the placebo group will cross over to the treatment group for the remainder of the study and all patients will be given a 60-day supply of treatment capsules covering the 90-day follow-up visit. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must be 40 years of age or older.
- Subjects must be applied to the Physical Treatment and Rehabilitation clinics with knee pain complaints and the subjects must be diagnosed as knee osteoarthritis exactly with routine laboratory and X-RAY degeneration detection methods. Subjects must have 2nd or 3rd grade knee osteoarthritis diagnose according to the Kellgren Lawrance criteria as a result of the knee graph determined with Anteroposterior (AP) graph method while standing on referencing American College of Rheumatology (ACR) or The European Leauge Aganist Rheumatism (EULAR) 2010.
- Male or female subjects can be included in the study.
- Subject must not have been diagnosed with a joint or connective tissue (JCT) disease other than osteoarthritis (i.e. rheumatoid arthritis, gout, pseudo gout, paget.) by a licensed physician prior to enrollment evaluation.
- Subject must have mild to moderate persistent joint pain lasting for at least 3 months with a score of at least 15 mm on a Patient's Assessment of Joint pain - WOMAC Osteoarthitiris Index and Visual Analog Scale (VAS).
Key exclusion criteria (11 listed)
- Subject has Grade IV (4) osteoarthritis (Kellgren-Lawrence) as judged by the clinical investigator
- Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, Tumor Necrosis Factor (TNF) alpha blockers, steroids and glucosamine condtroitin) or any investigational drug.
- Subject has been diagnosed with any confounding inflammatory disease or condition that would interfere with the assessment of the study treatment, as judged by the clinical investigator (i.e. pseudo gout, Paget's disease, chronic pain syndrome etc.).
- Subject has been enrolled in a study to evaluate a JCT treatment in the past 6 months.
- Subject has known allergy to eggs or egg products. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study.
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 |
|---|---|---|
| NEM brand eggshell membraneAlso: Natural Eggshell MembraneNEM 500 mg, once daily, p.o. | Dietary supplement | NEM brand eggshell membrane |
| PlaceboPlacebo, 500 mg, once daily, p.o. | Dietary supplement | Placebo |
Primary outcome
Change in Total WOMAC Score from Baseline
Time frame: 30 days
Clinical assessment of OA will be done using the Western Ontario and McMaster Universities Osteoarthritis Index ((WOMAC; v LK3.1: Turkish language translation) in the treatment group versus placebo. Possible score zero up to 96, with lower scores indicating better outcomes.
2 secondary outcomes
Change in Range of Motion (ROM) from Baseline as measured by goniometer
Time frame: 30 days
Safety Evaluations as measured by number of Participants with Adverse Event
Time frame: 90 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 22 Aug 2018.
- 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.
Meltem Çakmakgil, Dr. study director
Generica Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEM brand eggshell membrane in people with Osteoarthritis, Knee, run by Generica Pharmaceuticals at 8 sites in Turkey (Türkiye).
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 13 inclusion and 11 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye). 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?
Change in Total WOMAC Score from Baseline (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2018.