OsteoarthritisNCT00928837
Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
A study testing Flavocoxid 500 mg, Naproxen and flavocoxid 250 mg in people with Osteoarthritis, run by Primus Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Flavocoxid 500 mg, Naproxen and flavocoxid 250 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.
Read the detailed description
To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.
- Conditions
- Osteoarthritis
- Being tested
- Flavocoxid 500 mg, Naproxen, Placebo, flavocoxid 250 mg
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavocoxid 500 mgDietary supplement
Also called Limbrel 500 mg
flavonoid mixture
NaproxenDrug
Also called naprosyn
non-steroidal anti-inflammatory drug
PlaceboOther
Placebo
flavocoxid 250 mgOther
Also called Limbrel 250 mg
Medical food product
| Study group | Role | What they receive |
|---|---|---|
| flavocoxid 250 mg | Active comparator | Medical Food product Receives: Other: flavocoxid 250 mg |
| Naproxen | Active comparator | antiinflammatory Receives: Drug: Naproxen |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| flavocoxid 500 mg | Experimental | medical food product Receives: Dietary Supplement: Flavocoxid 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
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
Measured: 3 months
Secondary outcomes (2)
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startMar 2006
- Primary completionJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan J Kivitz, MD, Principal investigator, Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone 814-693-0300 Fax 814-693-0400Timothy S Truitt, MD, Principal investigator, Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone 321-723-1203 Fax 321-725-3602Joy Schechtman, DO, Principal investigator, Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623-362-9264David S Silver, MD, Principal investigator, 8691 Wilshire Blvd Suite 301 Beverly Hills CA 90211 phone 310-657-9650 Fax 310-659-2841Nathan Wei, MD, Principal investigator, Arthritis and Osteoporosis Center of Maryland71 Thomas Johnson Drive Frederick MD 21702 Phone 301-694-5800 Fax 301 694-0187Norman B Gayliss, MD, Principal investigator, 2845 Aventura Blvd. Suite 100 Aventura FL 33180 Phone 305-932-4295 Fax 305-932-6335David A. McLain, MD, Principal investigator, 2022 Brookwood Medical Center Drive Suite 211 Birmingham AL 35209 Phone 205-877-2555 Fax 205-877-2790
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928837
- Sponsor's protocol ID
- Primus Pharmaceuticals LOA-03P
- Status last verified
- Jun 2009
- First submitted
- 12 Nov 2008
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00928837
- Acronym / sponsor ID
- Primus Pharmaceuticals LOA-03P
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| flavocoxid 250 mg | Active comparator | Other: flavocoxid 250 mgMedical Food product |
| Naproxen | Active comparator | Drug: Naproxenantiinflammatory |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| flavocoxid 500 mg | Experimental | Dietary Supplement: Flavocoxid 500 mgmedical food product |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavocoxid 500 mgAlso: Limbrel 500 mgflavonoid mixture | Dietary supplement | flavocoxid 500 mg |
| NaproxenAlso: naprosynnon-steroidal anti-inflammatory drug | Drug | Naproxen |
| PlaceboPlacebo | Other | Placebo |
| flavocoxid 250 mgAlso: Limbrel 250 mgMedical food product | Other | flavocoxid 250 mg |
Primary outcome
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
Time frame: 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
Time frame: 3 months
Comparison of FS-36, subject tolerability VAS
2 secondary outcomes
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
Time frame: 6 months
to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Primus Pharmaceuticals,Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan J Kivitz, MD principal investigator
Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone 814-693-0300 Fax 814-693-0400
Timothy S Truitt, MD principal investigator
Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone 321-723-1203 Fax 321-725-3602
Joy Schechtman, DO principal investigator
Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623-362-9264
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavocoxid 500 mg, Naproxen and flavocoxid 250 mg in people with Osteoarthritis, run by Primus Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.