CompletedNCT00928837Updated Dec 13, 2017

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

An interventional study of Flavocoxid 500 mg and Naproxen in Osteoarthritis, sponsored by Primus Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by Primus Pharmaceuticals · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 350
Allocation: Randomized
Ages: 35 Years to 85 Years
Sex: All

Study 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.

Read the detailed description

To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.

Conditions studied

Osteoarthritis

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In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 350 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Primus Pharmaceuticals is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:Major inclusión criteria:

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

Major exclusion criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 350 participants (actual)

Study arms

Active comparator
flavocoxid 250 mg
Medical Food product
Other: flavocoxid 250 mg
Active comparator
Naproxen
antiinflammatory
Drug: Naproxen
Placebo comparator
Placebo
Placebo
Other: Placebo
Experimental
flavocoxid 500 mg
medical food product
Dietary Supplement: Flavocoxid 500 mg

Interventions

Dietary supplementFlavocoxid 500 mg
flavonoid mixture
Also known as: Limbrel 500 mg
DrugNaproxen
non-steroidal anti-inflammatory drug
Also known as: naprosyn
OtherPlacebo
Placebo
Otherflavocoxid 250 mg
Medical food product
Also known as: Limbrel 250 mg

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 3 months

Secondary outcomes

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
Time frame: 6 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
Time frame: 6 months

Study locations

1 site

Alan Kivitz MD
Duncansville, Pennsylvania 16635, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00928837
Lead sponsor: Primus Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 26, 2009
Start date: Mar 2006
Primary completion: Jun 2007
Completion: Sep 2007
Last update: Dec 13, 2017

Study contacts

Alan J Kivitz, MD

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

Timothy S Truitt, MD

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

Joy Schechtman, DO

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

David S Silver, MD

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

Nathan Wei, MD

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

Norman B Gayliss, MD

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

David A. McLain, MD

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

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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