Osteoarthritis of KneeNCT00790985
Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee
A study testing flavocoxid and Naproxen in people with Osteoarthritis of Knee, run by Primus Pharmaceuticals.
Trial summary
To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- flavocoxid and Naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to read and understand informed consent and questionnaires in English.
- Adults of either gender age 35-75 years, in general good health.
- Established X-ray diagnosis of osteoarthritis of at least one knee.
- Taken NSAID including COX-2 (cyclo-oxygenase-2) inhibitor in full therapeutic dose for at least one month prior to screening.
- Able and will to discontinue osteoarthritis medications until flare criteria met.
- BMI</= 45
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- Subjects must rate target knee at least 5 out of 10 on discomfort VAS (visual analogue scale) at baseline visit.
- Have an increase of at least 15mm on a 100mm pain VAS (visual analogue scale) from screening to baseline visit.
- Must use acceptable birth control if female.
- Screening fecal occult must be negative.
- Able to attend all required visits
- Physical Therapy is allowed as long as the type and frequency remains unchanged for the duration of the study.
Who cannot join
- Refusal to sign consent.
- Inability to attend all clinic visits
- Grade 0-1 K-L changes in both knees or grade 4 K-L changes in either knee on standing A/P radiograph
- Pregnant or lactating women
- History of serious cardio-vascular disease.
- Recurrent arrythmias, except paroxysmal tachycardia, cardiomyopathy, myocardial infarct within one year of screening.
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- History of chronic esophageal, gastric or duodenal disease
- History of upper GI bleeding within the past 2 years.
- Any GI disorder associated with malabsorption
- Any musculo-skeletal or neurological condition that results in pain or gait disturbance that might confound evaluation of target knee.
- Uncontrolled Diabetes Mellitus
- History of bleeding disorder or concurrent use of coumadin or any agent used to reduce blood clotting or platelet adhesiveness.
- Concurrent use of any anti-arthritic medication, including corticosteroids regardless of the reason for use. (low dose aspirin for cardioprotection is allowed)
- History of chronic renal disease with creatinine >2.0 or nephrotic syndrome with 24 hour protein excretion >1000mg.
- Intra-articular injection of any hyaluronic acid preparation in the target knee joint within 4 months of baseline visit.
- Intra-articular injection of a corticosteroid in the target knee joint within 2 months of the baseline visit.
- BMI>45
- History of allergic reaction to flavonoid or flavan containing foods or products (example: red wine, colored fruits and vegetable, brazil nuts, tea, natto)
- History of allergy to aspirin, naproxen or other NSAID
- History of substance abuse including alcohol, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
- Any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study.
- Participation in another clinical trial within 30 days or 7 half lives of the study agent, whichever is longer, of the screening visit.
About this study
Official title: Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis (OA) of the Knee
To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.
Read the detailed description
Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee.
- Conditions
- Osteoarthritis of Knee
- Being tested
- flavocoxid, Naproxen
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flavocoxidDietary supplement
Also called Limbrel
medical food
NaproxenDrug
Also called naprosyn
antiinflammatory drug
| Study group | Role | What they receive |
|---|---|---|
| flavocoxid 500 mg | Experimental | flavonoid mixture Receives: Dietary Supplement: flavocoxid |
| naproxen | Active comparator | nonsteroidal anti-inflammatory drug Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.
WOMAC is a composite of subscales: pain - 5 questions, stiffness - 2 questions, physical function - 17 questions. Subject answers each question as none=0, slight=1, moderate=2, very=3 and extreme=4 of pain, stiffness and difficulty of function. Scores for each subscale are summed, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).The higher the score of the units on the scale, the better the outcome.
For each individual subject, the percent change from baseline to Week 12 in the WOMAC composite score is calculated as 100 x (week 12 minus baseline)/baseline. The higher the percent change, the better the outcome. The percent changes from baseline to Week 12 are then compared between Flavocoxid and Naproxen.
Measured: As measured at Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of KneeStudies 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
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul H Caldron, DO, FACP, Study director, AmeRuss Clinical Trials LLC, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790985
- Sponsor's protocol ID
- LOA-04P
- Status last verified
- Oct 2015
- First submitted
- 16 Jan 2008
- Last updated
- 1 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: interested researchers may contact sponsor
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis (OA) of the Knee
- ClinicalTrials.gov ID
- NCT00790985
- Acronym / sponsor ID
- LOA-04P
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 1 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.
Detailed description
Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flavocoxid 500 mg | Experimental | Dietary Supplement: flavocoxidflavonoid mixture |
| naproxen | Active comparator | Drug: Naproxennonsteroidal anti-inflammatory drug |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to read and understand informed consent and questionnaires in English.
- Adults of either gender age 35-75 years, in general good health.
- Established X-ray diagnosis of osteoarthritis of at least one knee.
- Taken NSAID including COX-2 (cyclo-oxygenase-2) inhibitor in full therapeutic dose for at least one month prior to screening.
- Able and will to discontinue osteoarthritis medications until flare criteria met.
Key exclusion criteria (22 listed)
- Refusal to sign consent.
- Inability to attend all clinic visits
- Grade 0-1 K-L changes in both knees or grade 4 K-L changes in either knee on standing A/P radiograph
- Pregnant or lactating women
- History of serious cardio-vascular disease.
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 |
|---|---|---|
| flavocoxidAlso: Limbrelmedical food | Dietary supplement | flavocoxid 500 mg |
| NaproxenAlso: naprosynantiinflammatory drug | Drug | naproxen |
Primary outcome
Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.
Time frame: As measured at Baseline and Week 12
WOMAC is a composite of subscales: pain - 5 questions, stiffness - 2 questions, physical function - 17 questions. Subject answers each question as none=0, slight=1, moderate=2, very=3 and extreme=4 of pain, stiffness and difficulty of function. Scores for each subscale are summed, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).The higher the score of the units on the scale, the better the outcome. For each individual subject, the percent change from baseline to Week 12 in the WOMAC composite score is calculated as 100 x (week 12 minus baseline)/baseline. The higher the percent change, the better the outcome. The percent changes from baseline to Week 12 are then compared between Flavocoxid and Naproxen.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. interested researchers may contact 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.
Paul H Caldron, DO, FACP study director
AmeRuss Clinical Trials LLC, USA
Questions about this trial
What is this clinical trial studying?
A study testing flavocoxid and Naproxen in people with Osteoarthritis of Knee, run by Primus Pharmaceuticals.
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 12 inclusion and 22 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12. (time frame: As measured at Baseline and Week 12). 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 1 Nov 2022.