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

• Sponsor: Primus Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00928837
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 4
• Duration (Months): 18
• Patients Per Site Per Month: 19.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Dietary Supplement: Flavocoxid 500 mg; Drug: Naproxen; Other: Placebo; Other: flavocoxid 250 mg	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: flavocoxid 250 mg Medical Food product	Other: flavocoxid 250 mg; Medical food product; Other Names: Limbrel 250 mg
Active Comparator: Naproxen antiinflammatory	Drug: Naproxen; non-steroidal anti-inflammatory drug; Other Names: naprosyn
Placebo Comparator: Placebo Placebo	Other: Placebo; Placebo
Experimental: flavocoxid 500 mg medical food product	Dietary Supplement: Flavocoxid 500 mg; flavonoid mixture; Other Names: Limbrel 500 mg

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alan Kivitz MD	Duncansville	Pennsylvania	United States	16635

Sponsors and Collaborators

• Primus Pharmaceuticals

Investigators

• Principal Investigator: Alan J Kivitz, MD, Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone [phone] Fax [phone]
• Principal Investigator: Timothy S Truitt, MD, Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone [phone] Fax [phone]
• Principal Investigator: Joy Schechtman, DO, Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone [phone] Fax [phone]
• Principal Investigator: David S Silver, MD, 8691 Wilshire Blvd Suite 301 Beverly Hills CA 90211 phone [phone] Fax [phone]
• Principal Investigator: Nathan Wei, MD, Arthritis and Osteoporosis Center of Maryland71 Thomas Johnson Drive Frederick MD 21702 Phone [phone] Fax [phone]
• Principal Investigator: Norman B Gayliss, MD, 2845 Aventura Blvd. Suite 100 Aventura FL 33180 Phone [phone] Fax [phone]
• Principal Investigator: David A. McLain, MD, 2022 Brookwood Medical Center Drive Suite 211 Birmingham AL 35209 Phone [phone] Fax [phone]

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Primus Pharmaceuticals,Inc.

Publications

None provided.

• Responsible Party: Primus Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00928837
• Other Study ID Numbers: Primus Pharmaceuticals LOA-03P
• First Posted: Jun 26, 2009
• Last Update Posted: Dec 13, 2017
• Last Verified: Jun 1, 2009

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Naproxen

Study Results

No Results Posted as of Dec 13, 2017