Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

NCT00928837 | Completed

• 1 other identifier: Primus Pharmaceuticals LOA-03P
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

  comparison of short WOMAC and timed walk

  3 months

• to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

  Comparison of FS-36, subject tolerability VAS

  3 months

Secondary Outcomes (2)

• to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

  6 months

• to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

  6 months

Study Arms (4)

flavocoxid 250 mg

ACTIVE COMPARATOR

Medical Food product

Other: flavocoxid 250 mg

Naproxen

ACTIVE COMPARATOR

antiinflammatory

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

flavocoxid 500 mg

EXPERIMENTAL

medical food product

Dietary Supplement: Flavocoxid 500 mg

Interventions

Flavocoxid 500 mg DIETARY_SUPPLEMENT

flavonoid mixture

Also known as: Limbrel 500 mg

flavocoxid 500 mg

Naproxen DRUG

non-steroidal anti-inflammatory drug

Also known as: naprosyn

Naproxen

Placebo OTHER

Placebo

Placebo

flavocoxid 250 mg OTHER

Medical food product

Also known as: Limbrel 250 mg

flavocoxid 250 mg

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of either gender, ages 35-85, in general good health
• Diagnosed with OA of the knee, K-L Grade 2-3
• History of positive response to NSAID's or COX-2 inhibitors
• Able and willing to discontinue other medicinal OA therapies for length of the study (subjects may continue low dose aspirin for cardioprotection)
• Females of child bearing potential must use acceptable method of birth control

You may not qualify if:

• Unwilling or unable to read and sign informed consent document
• Pregnant and nursing women
• History of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year
• K-L grade 1 or 4 OA of the target knee
• chronic bleeding disorder or present use of anticoagulants
• History of upper G-I bleed in the past 5 years
• Significant renal disease including nephrotic syndrome, proteinuria \>1 gm/24 hrs or serum Creatinine \>2.0
• Any arthritic disease that is or has the potential to affect the knees during the course of the study
• Any other condition that might confound evaluation of the target joint including, but not limited to, bursitis, tendonitis or internal derangement in or about the knee, gait disturbances (e.g. mechanical, neurological conditions or disorders of the back), fibromyalgia, polyneuropathies, etc.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead

Study Sites (1)

Alan Kivitz MD

Duncansville, Pennsylvania, 16635, United States

Location

Related Links

• Primus Pharmaceuticals,Inc.

MeSH Terms

Conditions

Osteoarthritis

Interventions

flavocoxid; Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Alan J Kivitz, MD

  Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone 814-693-0300 Fax 814-693-0400

  PRINCIPAL INVESTIGATOR

• Timothy S Truitt, MD

  Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone 321-723-1203 Fax 321-725-3602

  PRINCIPAL INVESTIGATOR

• Joy Schechtman, DO

  Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623-362-9264

  PRINCIPAL INVESTIGATOR

• David S Silver, MD

  8691 Wilshire Blvd Suite 301 Beverly Hills CA 90211 phone 310-657-9650 Fax 310-659-2841

  PRINCIPAL INVESTIGATOR

• Nathan Wei, MD

  Arthritis and Osteoporosis Center of Maryland71 Thomas Johnson Drive Frederick MD 21702 Phone 301-694-5800 Fax 301 694-0187

  PRINCIPAL INVESTIGATOR

• Norman B Gayliss, MD

  2845 Aventura Blvd. Suite 100 Aventura FL 33180 Phone 305-932-4295 Fax 305-932-6335

  PRINCIPAL INVESTIGATOR

• David A. McLain, MD

  2022 Brookwood Medical Center Drive Suite 211 Birmingham AL 35209 Phone 205-877-2555 Fax 205-877-2790

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: June 26, 2009
• Study Start: March 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: September 1, 2007
• Last Updated: December 13, 2017

Record last verified: 2009-06

Locations

US (1)