Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study
1 other identifier
interventional
60
1 country
1
Brief Summary
safety, efficacy and acceptability of Flavocoxid
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 13, 2006
CompletedFirst Posted
Study publicly available on registry
March 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedOctober 21, 2015
November 1, 2008
4 months
March 13, 2006
October 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
compare efficacy
Secondary Outcomes (1)
evaluate safety
Study Arms (2)
flavocoxid
EXPERIMENTALmedical food
naproxen
ACTIVE COMPARATORNSAID
Interventions
Eligibility Criteria
You may qualify if:
- OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Timothy Truitt MD
Melbourne, Florida, 32901, United States
Related Publications (1)
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.
PMID: 19555810DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joy Schechtman, DO
Sun Valley Arthritis Ltd, 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623
- PRINCIPAL INVESTIGATOR
Timothy Truitt, MD
MIMA Century Research Associates 65 E. Nasa Blvd. Suite 106 Melbourne FL 32901 Phone 321 723-1203 Fax 321-725-3602
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2006
First Posted
March 15, 2006
Study Start
March 1, 2006
Primary Completion
July 1, 2006
Study Completion
September 1, 2006
Last Updated
October 21, 2015
Record last verified: 2008-11