Efficacy of Myalgesin™ to Support Joint Function in Patients With Knee Osteoarthritis

NCT00577330 | Unknown Phase 3

• 2 other identifiers: MYG-01-200620052687
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have been shown to exert anti-inflammatory effects and to inhibit cyclooxygenase and 5-lipooxygenase. The study is based on the hypothesis that oral administrration of this botanical will support joint function in people with osteoarthritis of the knee and improve symptoms and mobility as measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

  90 days

Secondary Outcomes (1)

• Lesquesne Algofunctional Index

  90 days

Study Arms (2)

Myalgesin

EXPERIMENTAL

Subjects receive Myalgesin twice daily

Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)

Acetaminophen

ACTIVE COMPARATOR

Subjects receive acetaminophen 1000 mg three times a day

Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)

Interventions

Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract) DIETARY_SUPPLEMENT

Twice daily

Acetaminophen; Myalgesin

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 50-years or older.
• Patients with symptomatic osteoarthritis of the knees as defined by the American College of Rheumatology criteria(traditional format).
• At least moderate pain in the knee (rated at 40 or greater by the subject on a visual analogue scale) for most days during the last month.
• Use of analgesic or anti-inflammatory agents for control of pain for at least 1 month.
• Baseline functional capacity class 1 to 3, in which class 1 is complete ability to carry out usual activities without handicap,class 2 is ability to adequately conduct usual activities despite handicap of discomfort or limited mobility of one or more joints,and class 3 is limited ability to carry out usual activities. (American Rheumatism Association functional class)
• Documented radiographic changes of osteoarthritis on a previous knee radiograph (Kellgren-Lawrence grade of 2 or more).

You may not qualify if:

• Age \<50-years.
• Body mass index (BMI) equal to or greater than 35 kg/m2.
• Baseline functional class 4 with the subject bedridden or confined to wheelchair, largely or wholly incapacitated and capable of little or no self-care. (American Rheumatism Association functional class)
• Inflammatory arthritis, gout, pseudogout, or Paget's disease.
• Presence of chronic pain syndromes, such as fibromyalgia or reflex sympathetic dystrophy, that may interfere with the assessment of joint symptomatology.
• Severe bursitis of the knee.
• History of acute joint trauma within 30 days of study entry.
• Complete loss of articular cartilage.
• History of total knee replacement.
• Intra-articular/intramuscular corticosteroids within 30 days of study entry.
• Intra-articular hyaluronan and hyalans within 30 days of study entry.
• History of gastrointestinal bleeding within 1 year of study entry.
• Active peptic ulcer disease, gastroesophageal reflux disease, or inflammatory bowel disease.
• Gastrointestinal tract ulceration within 30 days of study entry.
• Severe renal dysfunction defined as a serum creatinine greater than 2 mg/dL.

Sponsors & Collaborators

• ProThera, Inc.: lead

Study Sites (1)

Stuart I. Erner, MD

Albany, New York, 12203, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Frankincense; cortex Phellodendron

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Stuart I Erner, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: May 1, 2006
• Study Completion: January 1, 2008
• Last Updated: December 28, 2007

Record last verified: 2007-12

Locations

US (1)