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

Osteoarthritis Clinical Trial

Official title:

A Double-Blind,Randomized, Placebo Controlled, Parallel Group, Multi-Center Study of Flavocoxid (Limbrel) Versuss Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928837
• Other study ID #: Primus Pharmaceuticals LOA-03P
• Status: Completed
• Phase: N/A
• First received: November 12, 2008
• Last updated: December 11, 2017
• Start date: March 2006
• Est. completion date: September 2007

Study information

• Verified date: June 2009
• Source: Primus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Flavocoxid 500 mg
flavonoid mixture

Drug:
• Naproxen
non-steroidal anti-inflammatory drug

Other:
• Placebo
Placebo
• flavocoxid 250 mg
Medical food product

Locations

Country	Name	City	State
United States	Alan Kivitz MD	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Primus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	6 months
Secondary	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	6 months

External Links

•   Primus Pharmaceuticals,Inc.