OsteoarthritisNCT00435292
Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee
A study testing Naproxen, flavocoxid 250 mg and flavocoxid 500 mg in people with Osteoarthritis, run by Primus Pharmaceuticals at 1 site in United States.
Trial summary
Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Naproxen, flavocoxid 250 mg and flavocoxid 500 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 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
- OA of the Knee
- K-L Grade 2-3
- Positive response to NSAIDS
Who cannot join
- K-L grade 1 0r 4 OA of the knee
- History of GI Bleed within past 5 years
- Chronic bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Primus Pharmaceuticals, Inc
Scottsdale, Arizona, 85251
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi Center Study of Flavocoxid ( Limbrel) vs Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.
Read the detailed description
This will be a randomized, double blind, placebo controlled, parallel group, multi-center study in subjects with moderate-severe OA. Subjects will be randomized to receive flavocoxid 250 mg bid, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio. Subjects will take study materials twice daily for twelve (12) weeks. After the 12 week visit subjects in the placebo arm will be re-randomized to the two flavocoxid arms. All subjects will then continue on the study for an additional 12 weeks.
Subjects will keep a diary noting date of onset of symptom change (better or worse), adverse events and cost of all aspects of medical care related directly or indirectly to osteoarthritis.
Laboratory studies for inflammatory markers will be drawn and archived at baseline and at the 12 week visit. In addition, a subgroup of subjects will have arthrocenteses performed at baseline and the 12 week visit and the synovial fluid archived for study of intra-articular inflammatory markers.
- Conditions
- Osteoarthritis
- Being tested
- Naproxen, flavocoxid 250 mg, flavocoxid 500 mg
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Also called naprosyn
nonsteroidal anti-inflammatory drug
flavocoxid 250 mgDietary supplement
Also called Limbrel 250 mg
flavonoid mixture
flavocoxid 500 mgDietary supplement
Also called limbrel 500 mg
flavonoid mixture
| Study group | Role | What they receive |
|---|---|---|
| flavocoxid 250 mg | Experimental | flavonoid mixture Receives: Dietary Supplement: flavocoxid 250 mg |
| flavocoxid 500 mg | Active comparator | flavonoid mixture Receives: Dietary Supplement: flavocoxid 500 mg |
| naproxen | Active comparator | nonsteroidal antiinflammatory drug Receives: Drug: Naproxen |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startApr 2006
- Primary completionDec 2007
- Study completionDec 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
- Robert M Levy, MD, Study director, Primus Pharmaceuticals,IncAlan Kivitz, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435292
- Sponsor's protocol ID
- LOA-03P
- Status last verified
- Nov 2008
- First submitted
- 12 Feb 2007
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. 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) vs Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00435292
- Acronym / sponsor ID
- LOA-03P
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Feb 2007 (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.
Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.
Detailed description
This will be a randomized, double blind, placebo controlled, parallel group, multi-center study in subjects with moderate-severe OA. Subjects will be randomized to receive flavocoxid 250 mg bid, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio. Subjects will take study materials twice daily for twelve (12) weeks. After the 12 week visit subjects in the placebo arm will be re-randomized to the two flavocoxid arms. All subjects will then continue on the study for an additional 12 weeks.
Subjects will keep a diary noting date of onset of symptom change (better or worse), adverse events and cost of all aspects of medical care related directly or indirectly to osteoarthritis.
Laboratory studies for inflammatory markers will be drawn and archived at baseline and at the 12 week visit. In addition, a subgroup of subjects will have arthrocenteses performed at baseline and the 12 week visit and the synovial fluid archived for study of intra-articular inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| flavocoxid 250 mg | Experimental | Dietary Supplement: flavocoxid 250 mgflavonoid mixture |
| flavocoxid 500 mg | Active comparator | Dietary Supplement: flavocoxid 500 mgflavonoid mixture |
| naproxen | Active comparator | Drug: Naproxennonsteroidal antiinflammatory drug |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OA of the Knee
- K-L Grade 2-3
- Positive response to NSAIDS
Key exclusion criteria (3 listed)
- K-L grade 1 0r 4 OA of the knee
- History of GI Bleed within past 5 years
- Chronic bleeding disorder
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 |
|---|---|---|
| NaproxenAlso: naprosynnonsteroidal anti-inflammatory drug | Drug | naproxen |
| flavocoxid 250 mgAlso: Limbrel 250 mgflavonoid mixture | Dietary supplement | flavocoxid 250 mg |
| flavocoxid 500 mgAlso: limbrel 500 mgflavonoid mixture | Dietary supplement | flavocoxid 500 mg |
Primary outcome
Not reported in the source record.
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 21 Oct 2015.
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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.
Robert M Levy, MD study director
Primus Pharmaceuticals,Inc
Alan Kivitz, MD principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naproxen, flavocoxid 250 mg and flavocoxid 500 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 3 inclusion and 3 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 21 Oct 2015. 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. 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.
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 21 Oct 2015.