NCT00750477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

September 8, 2008

Last Update Submit

February 11, 2016

Conditions

Osteoarthritis

Keywords

osteoarthritisarthritiskneeeggshellmembraneOPTION

Outcome Measures

Primary Outcomes (1)

  • 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.

    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®.

    10, 30, & 60 Days

Study Arms (2)

NEM Treatment

EXPERIMENTAL

NEM, 500 mg, once daily, orally for 8 weeks

Dietary Supplement: NEM

Placebo

PLACEBO COMPARATOR

Placebo, 500 mg, once daily, orally for 8 weeks

Dietary Supplement: Placebo

Interventions

NEMDIETARY_SUPPLEMENT

see Treatment Arms

Also known as: Natural Eggshell Membrane
NEM Treatment
PlaceboDIETARY_SUPPLEMENT

Placebo comparator containing inactives

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Regional Specialty Clinic

Cuba, Missouri, 65453, United States

Location

Regional Specialty Clinic

Kirksville, Missouri, 63501, United States

Location

St. John's Clinic

Springfield, Missouri, 65807, United States

Location

Related Publications (1)

  • 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.

    PMID: 19340512RESULT

Related Links

MeSH Terms

Conditions

OsteoarthritisArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Anne Winkler, MD, PhD

    St. John's Clinic - Rheumatology

    PRINCIPAL INVESTIGATOR

  • Robert W Jackson, DO

    Regional Specialty Clinic

    PRINCIPAL INVESTIGATOR

  • Kevin J Ruff, PhD, MBA

    ESM Technologies, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 10, 2008

Study Start

December 1, 2004

Primary Completion

January 1, 2006

Study Completion

May 1, 2006

Last Updated

February 15, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)