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

This study has been completed.

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

Sponsored by:	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

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Naproxen
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Rheumatic Diseases
Osteoarthritis, Knee

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Rheumatic Diseases
Gout Suppressants
Pharmacologic Actions

Osteoarthritis, Knee
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009