Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee

This study has been completed.

First Received on February 12, 2007. Last Updated on November 12, 2008 History of Changes

Sponsor:	Primus Pharmaceuticals
Information provided by:	Primus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00435292

Purpose

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

Condition	Intervention	Phase
Osteoarthritis	Drug: Naproxen Drug: Limbrel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Primus Pharmaceuticals:

Estimated Enrollment:	350
Study Start Date:	April 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	35 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435292

Locations

United States, Arizona
Primus Pharmaceuticals, Inc
Scottsdale, Arizona, United States, 85251

Sponsors and Collaborators

Primus Pharmaceuticals

Investigators

Study Director:	Robert M Levy, MD	Primus Pharmaceuticals,Inc
Principal Investigator:	Alan Kivitz, MD	Private Practice

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00435292 History of Changes
Other Study ID Numbers:	LOA-03P
Study First Received:	February 12, 2007
Last Updated:	November 12, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012