NCT00435292

Brief Summary

Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

April 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 21, 2015

Status Verified

November 1, 2008

Enrollment Period

1.7 years

First QC Date

February 12, 2007

Last Update Submit

October 19, 2015

Conditions

Osteoarthritis

Study Arms (3)

flavocoxid 250 mg

EXPERIMENTAL

flavonoid mixture

Dietary Supplement: flavocoxid 250 mg

flavocoxid 500 mg

ACTIVE COMPARATOR

flavonoid mixture

Dietary Supplement: flavocoxid 500 mg

naproxen

ACTIVE COMPARATOR

nonsteroidal antiinflammatory drug

Drug: Naproxen

Interventions

NaproxenDRUG

nonsteroidal anti-inflammatory drug

Also known as: naprosyn
naproxen
flavocoxid 250 mgDIETARY_SUPPLEMENT

flavonoid mixture

Also known as: Limbrel 250 mg
flavocoxid 250 mg
flavocoxid 500 mgDIETARY_SUPPLEMENT

flavonoid mixture

Also known as: limbrel 500 mg
flavocoxid 500 mg

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OA of the Knee
  • K-L Grade 2-3
  • Positive response to NSAIDS

You may not qualify if:

  • K-L grade 1 0r 4 OA of the knee
  • History of GI Bleed within past 5 years
  • Chronic bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primus Pharmaceuticals, Inc

Scottsdale, Arizona, 85251, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Naproxenflavocoxid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Robert M Levy, MD

    Primus Pharmaceuticals,Inc

    STUDY DIRECTOR

  • Alan Kivitz, MD

    Private Practice

    PRINCIPAL INVESTIGATOR

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

February 12, 2007

First Posted

February 14, 2007

Study Start

April 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 21, 2015

Record last verified: 2008-11

Locations

US(1)