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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Flavocoxid 500 mg

Naproxen

Placebo

flavocoxid 250 mg

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Alan Kivitz MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

flavocoxid 250 mg

Naproxen

Placebo

flavocoxid 500 mg

Arm Description

Medical Food product

antiinflammatory

Placebo

medical food product

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00928837

First Posted

November 12, 2008

Last Updated

December 11, 2017

Sponsor

Primus Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00928837

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Primus Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

350 (Actual)

8. Arms, Groups, and Interventions

Arm Title

flavocoxid 250 mg

Arm Type

Active Comparator

Arm Description

Medical Food product

Arm Title

Naproxen

Arm Type

Active Comparator

Arm Description

antiinflammatory

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

flavocoxid 500 mg

Arm Type

Experimental

Arm Description

medical food product

Intervention Type

Dietary Supplement

Intervention Name(s)

Flavocoxid 500 mg

Other Intervention Name(s)

Limbrel 500 mg

Intervention Description

flavonoid mixture

Intervention Type

Drug

Intervention Name(s)

Naproxen

Other Intervention Name(s)

naprosyn

Intervention Description

non-steroidal anti-inflammatory drug

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Other

Intervention Name(s)

flavocoxid 250 mg

Other Intervention Name(s)

Limbrel 250 mg

Intervention Description

Medical food product

Primary Outcome Measure Information:

Title

to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

Description

comparison of short WOMAC and timed walk

Time Frame

3 months

Title

to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

Description

Comparison of FS-36, subject tolerability VAS

Time Frame

3 months

Secondary Outcome Measure Information:

Title

to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

Description

comparison of short WOMAC and timed walk

Time Frame

6 months

Title

to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks

Description

Comparison of FS-36, subject tolerability VAS

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: