OsteoarthritisNCT00303017
Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study
A study testing flavocoxid and Naproxen in people with Osteoarthritis, run by Primus Pharmaceuticals at 1 site in United States.
Trial summary
safety, efficacy and acceptability of Flavocoxid Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- flavocoxid and Naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Sep 2006
- 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 30 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 in general good health is currently taking an NSAID or COX-2 inhibitor -
Who cannot join
- pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study
safety, efficacy and acceptability of Flavocoxid
Read the detailed description
Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study
- Conditions
- Osteoarthritis
- Being tested
- flavocoxid, Naproxen
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flavocoxidDietary supplement
Also called Limbrel
flavonoid mixture
NaproxenDrug
Also called naprosyn
non-steroidal anti-inflammatory drug
| Study group | Role | What they receive |
|---|---|---|
| flavocoxid | Experimental | medical food Receives: Dietary Supplement: flavocoxid |
| naproxen | Active comparator | NSAID Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare efficacy
Secondary outcomes (1)
evaluate safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joy Schechtman, DO, Principal investigator, Sun Valley Arthritis Ltd, 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623Timothy Truitt, MD, Principal investigator, MIMA Century Research Associates 65 E. Nasa Blvd. Suite 106 Melbourne FL 32901 Phone 321 723-1203 Fax 321-725-3602
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303017
- Sponsor's protocol ID
- Primus Protocol #OAPS
- Status last verified
- Nov 2008
- First submitted
- 13 Mar 2006
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Levy RM, Saikovsky R, Shmidt E, Khokhlov A, Burnett BP. Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized, double-blind pilot study. Nutr Res. 2009 May;29(5):298-304. doi: 10.1016/j.nutres.2009.04.003.
PubMed 19555810
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
- Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study
- ClinicalTrials.gov ID
- NCT00303017
- Acronym / sponsor ID
- Primus Protocol #OAPS
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 15 Mar 2006 (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.
safety, efficacy and acceptability of Flavocoxid
Detailed description
Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study
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 | Experimental | Dietary Supplement: flavocoxidmedical food |
| naproxen | Active comparator | Drug: NaproxenNSAID |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -
Key exclusion criteria (2 listed)
- pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids
- -
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: Limbrelflavonoid mixture | Dietary supplement | flavocoxid |
| NaproxenAlso: naprosynnon-steroidal anti-inflammatory drug | Drug | naproxen |
Primary outcome
compare efficacy
1 secondary outcome
evaluate safety
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.
- Derived from this study: PubMed 19555810Levy RM, Saikovsky R, Shmidt E, Khokhlov A, Burnett BP. Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized, double-blind pilot study. Nutr Res. 2009 May;29(5):298-304. doi: 10.1016/j.nutres.2009.04.003.
- Primus Pharmaceuticals, IncLink 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.
Joy Schechtman, DO principal investigator
Sun Valley Arthritis Ltd, 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623
Timothy Truitt, MD principal investigator
MIMA Century Research Associates 65 E. Nasa Blvd. Suite 106 Melbourne FL 32901 Phone 321 723-1203 Fax 321-725-3602
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 and Naproxen 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 1 inclusion and 2 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.
What does the primary outcome measure?
compare efficacy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00303017, which also lists 1 linked publication.
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.