Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee

NCT00790985 | Completed Results DMC

• 1 other identifier: LOA-04P
• Study Type: interventional
• Target: 223
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.

  WOMAC is a composite of subscales: pain - 5 questions, stiffness - 2 questions, physical function - 17 questions. Subject answers each question as none=0, slight=1, moderate=2, very=3 and extreme=4 of pain, stiffness and difficulty of function. Scores for each subscale are summed, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).The higher the score of the units on the scale, the better the outcome. For each individual subject, the percent change from baseline to Week 12 in the WOMAC composite score is calculated as 100 x (week 12 minus baseline)/baseline. The higher the percent change, the better the outcome. The percent changes from baseline to Week 12 are then compared between Flavocoxid and Naproxen.

  As measured at Baseline and Week 12

Study Arms (2)

flavocoxid 500 mg

EXPERIMENTAL

flavonoid mixture

Dietary Supplement: flavocoxid

naproxen

ACTIVE COMPARATOR

nonsteroidal anti-inflammatory drug

Drug: Naproxen

Interventions

flavocoxid DIETARY_SUPPLEMENT

medical food

Also known as: Limbrel

flavocoxid 500 mg

Naproxen DRUG

antiinflammatory drug

Also known as: naprosyn

naproxen

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to read and understand informed consent and questionnaires in English.
• Adults of either gender age 35-75 years, in general good health.
• Established X-ray diagnosis of osteoarthritis of at least one knee.
• Taken NSAID including COX-2 (cyclo-oxygenase-2) inhibitor in full therapeutic dose for at least one month prior to screening.
• Able and will to discontinue osteoarthritis medications until flare criteria met.
• BMI\</= 45
• Subjects must rate target knee at least 5 out of 10 on discomfort VAS (visual analogue scale) at baseline visit.
• Have an increase of at least 15mm on a 100mm pain VAS (visual analogue scale) from screening to baseline visit.
• Must use acceptable birth control if female.
• Screening fecal occult must be negative.
• Able to attend all required visits
• Physical Therapy is allowed as long as the type and frequency remains unchanged for the duration of the study.

You may not qualify if:

• Refusal to sign consent.
• Inability to attend all clinic visits
• Grade 0-1 K-L changes in both knees or grade 4 K-L changes in either knee on standing A/P radiograph
• Pregnant or lactating women
• History of serious cardio-vascular disease.
• Recurrent arrythmias, except paroxysmal tachycardia, cardiomyopathy, myocardial infarct within one year of screening.
• History of chronic esophageal, gastric or duodenal disease
• History of upper GI bleeding within the past 2 years.
• Any GI disorder associated with malabsorption
• Any musculo-skeletal or neurological condition that results in pain or gait disturbance that might confound evaluation of target knee.
• Uncontrolled Diabetes Mellitus
• History of bleeding disorder or concurrent use of coumadin or any agent used to reduce blood clotting or platelet adhesiveness.
• Concurrent use of any anti-arthritic medication, including corticosteroids regardless of the reason for use. (low dose aspirin for cardioprotection is allowed)
• History of chronic renal disease with creatinine \>2.0 or nephrotic syndrome with 24 hour protein excretion \>1000mg.
• Intra-articular injection of any hyaluronic acid preparation in the target knee joint within 4 months of baseline visit.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

flavocoxid; Naproxen

Condition Hierarchy (Ancestors)

Osteoarthritis; 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

Results Point of Contact

• Title: Robert Levy, MD., Director of Clinical Development
• Organization: Primus Pharmaceuticals

Rlevy@primusrx.com

480-483-1410

Study Officials

• Paul H Caldron, DO, FACP

  AmeRuss Clinical Trials LLC, USA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: January 16, 2008
• First Posted: November 14, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 1, 2022
• Results First Posted: November 1, 2022

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share