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Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study

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Primus Pharmaceuticals

Status

Completed

Conditions

Osteoarthritis

Treatments

Dietary Supplement: flavocoxid
Drug: Naproxen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00303017
Primus Protocol #OAPS

Details and patient eligibility

About

safety, efficacy and acceptability of Flavocoxid

Full description

Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study

Enrollment

60 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -

Exclusion criteria

pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

flavocoxid
Experimental group
Description:
medical food
Treatment:
Dietary Supplement: flavocoxid
naproxen
Active Comparator group
Description:
NSAID
Treatment:
Drug: Naproxen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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