Efficacy and Safety of NEM® Brand Eggshell Membrane in Patients With Grade 2/3 Knee Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02291757
• Date of registration: 03/11/2014
• Prospective Registration: No
• Primary sponsor: Generica Pharmaceuticals
• Public title: Efficacy and Safety of NEM® Brand Eggshell Membrane in Patients With Grade 2/3 Knee Osteoarthritis
• Scientific 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
• Date of first enrolment: October 2013
• Target sample size: 166
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02291757
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Turkey

Contacts

• Name: Meltem Çakmakgil, Dr.
• Affiliation: Generica Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects must be 40 years of age or older.

2. 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.

3. Male or female subjects can be included in the study.

4. 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.

5. 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).

6. Subjects must have disease complaints for at least 1-5 years.

7. Subject must diagnosed with 2nd or 3rd grade knee osteoarthritis according to Kellgren
Lawrance criteria.

8. Body mess index of the subjects must be 35 or below.

9. Subject must be available for and willing to attend all evaluation visits.

10. Subject must be able and willing to give informed consent.

11. 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.

a. 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.)

12. Subjects must be willing to use only paracetamol as rescue pain medication, provided
as part of the study.

Exclusion Criteria:

1. Subject has Grade IV (4) osteoarthritis (Kellgren-Lawrence) as judged by the clinical
investigator

2. 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.

3. 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.).

4. Subject has been enrolled in a study to evaluate a JCT treatment in the past 6 months.

5. 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.

a. Such sensitivity may be realized as a reaction to inoculations wherein the
inoculate is derived from or contains egg components (i.e., influenza vaccine).

6. Subject body mess index greater than 35.

7. Pregnant and breastfeeding women.

8. 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).

9. Subject is unwilling to forgo use of prescription, over-the-counter (OTC) treatments,
and/or dietary supplements for the duration of the study.

10. 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis, Knee

Intervention(s)

Dietary Supplement: NEM brand eggshell membrane

Dietary Supplement: Placebo

Primary Outcome(s)

Change in Total WOMAC Score from Baseline [Time Frame: 30 days]

Secondary Outcome(s)

Safety Evaluations as measured by number of Participants with Adverse Event [Time Frame: 90 days]

Change in Range of Motion (ROM) from Baseline as measured by goniometer [Time Frame: 30 days]

Secondary ID(s)

U1111-1151-1846

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Optimum Contract Research Organisation