NCT00294125

Brief Summary

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to treat arthritis. The purpose of this study is to test the effectiveness of flavocoxid, a plant-derived compound, for the treatment of knee osteoarthritis (OA) in adults. Study hypotheses: 1) Flavocoxid has an acceptable safety and tolerability profile as determined by the Generally Regarded as Safe (GRAS) profile in patients with OA compared to identical placebo. 2) Flavocoxid will be more effective as a therapy for OA compared to identical placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

February 16, 2006

Last Update Submit

April 19, 2013

Conditions

Osteoarthritis

Keywords

Medical FoodBotanicalsPhytochemicals

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of flavocoxid (clinical status; causality and occurrence of adverse events)

    Measured throughout 12-week treatment period

Secondary Outcomes (1)

  • Efficacy of treatment and clinical benefit

    Measured at Week 12

Study Arms (2)

1

EXPERIMENTAL

Participants will receive daily flavocoxid for 12 weeks.

Drug: Flavocoxid

2

PLACEBO COMPARATOR

Participants will receive placebo for 12 weeks.

Drug: Placebo

Interventions

FlavocoxidDRUG

Daily flavocoxid for 12 weeks

1
PlaceboDRUG

Daily placebo for 12 weeks

2

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet American College of Rheumatology (ACR) clinical criteria for knee OA
  • In good medical and psychological health
  • Able and willing to discontinue NSAIDs, natural therapies, and other pain medications for OA for 1 week prior to the first study visit and also throughout the course of the clinical trial
  • Knee pain rated greater than 4 cm on a 10 cm visual analog scale (VAS)
  • Intends to stay in the area and complete the 12-week protocol
  • Willing to use acceptable forms of contraception

You may not qualify if:

  • Serious or unstable concomitant medical or psychological illnesses that would impair the patient's ability to complete the study
  • Significant cardiac disease OR history of myocardial infarction in the 12 months prior to study entry
  • Uncontrolled hypertension
  • Significant bleeding disorders. Participants who have bleeding disorders related to uncontrolled, bleeding hemorrhoids occurring in the 12 months prior to study entry are not excluded.
  • Uncontrolled gastrointestinal disease resulting in bleeding in the 60 days prior to study entry. Participants with controlled and uncomplicated ulcers are not excluded.
  • Inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome
  • Severe pes anserine bursitis, acute joint trauma, or complete loss of articular cartilage on the index knee
  • Intravenous, intramuscular, or intra-articular steroids to the index joint within 60 days of study screening
  • Alcohol, intravenous drug, or prescription drug abuse
  • Investigational drugs within 30 days of study screening
  • Current use of anticoagulants such as warfarin
  • Oral corticosteroids or other immunosuppressants within 6 months of study screening
  • Severe psoriasis requiring use of biologic immunomodulators such as alefacept, etanercept, infliximab, or cyclosporine
  • Hypersensitivity to analgesics, cyclo-oxygenase inhibitors, lipoxygenase inhibitors, or flavonoids
  • Pregnancy or breastfeeding
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Morgan SL, Baggott JE, Moreland L, Desmond R, Kendrach AC. The safety of flavocoxid, a medical food, in the dietary management of knee osteoarthritis. J Med Food. 2009 Oct;12(5):1143-8. doi: 10.1089/jmf.2008.0244.

    PMID: 19857081RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

flavocoxid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sarah L. Morgan, MD, RD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

US(1)