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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: flavocoxid 250 mg; Dietary Supplement: Flavocoxid 500 mg; Other: Placebo; Drug: Naproxen

• Registration Number: NCT00928837
• Lead Sponsor: Primus Pharmaceuticals

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.

Detailed Description

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

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-06
• Study Completion: 2007-09
• Study First Submitted: 2008-11-12
• Status Verified: 2009-06
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Major inclusión criteria:

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

Major exclusion criteria:

1. Unwilling or unable to read and sign informed consent document
2. Pregnant and nursing women
3. History of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year
4. K-L grade 1 or 4 OA of the target knee
5. chronic bleeding disorder or present use of anticoagulants
6. History of upper G-I bleed in the past 5 years
7. Significant renal disease including nephrotic syndrome, proteinuria >1 gm/24 hrs or serum Creatinine >2.0
8. Any arthritic disease that is or has the potential to affect the knees during the course of the study
9. 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flavocoxid 250 mg	flavocoxid 250 mg	Medical Food product
flavocoxid 500 mg	Flavocoxid 500 mg	medical food product
Placebo	Placebo	Placebo
Naproxen	Naproxen	antiinflammatory

Primary Outcome Measures

Name	Time	Method
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	3 months	comparison of short WOMAC and timed walk
to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	3 months	Comparison of FS-36, subject tolerability VAS

Secondary Outcome Measures

Name	Time	Method
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	6 months	comparison of short WOMAC and timed walk
to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	6 months	Comparison of FS-36, subject tolerability VAS

Trial Locations

Locations (1)

Alan Kivitz MD; 🇺🇸 Duncansville, Pennsylvania, United States