Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg Versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients With Osteoarthritis

Inclusion Criteria:

• Males and females over the age of 18
• The patient, if female and of reproductive potential (i.e. neither surgically sterilized nor post-menopausal), must be practicing adequate contraception (e.g. intrauterine device, contraceptive pills, Depo-Provera, or implant or double barrier device) for at least three months prior to and for the duration of their trial participation and must have a negative pregnancy test at screening. Abstinence is not considered to be an acceptable method of contraception. (It should be noted that NSAIDs might interfere with the effectiveness of intrauterine devices)

• The patient must have a documented diagnosis of at least one of the following:

  • Osteoarthritis of the hip
  • Osteoarthritis of the knee
  • Osteoarthritis of the hand or
  • Osteoarthritis of the spine - Patients must have radiographic confirmation of the diagnosis
• The patient is willing to change or requires a change in current prescription NSAID therapy or requires initiation of prescription NSAID therapy for treatment of OA of the hip, knee, hand or spine
• The patient intends to remain a member of their present Managed Care Organization (MCO) for the duration of the trial
• The patient is willing to comply with instructions and to provide written informed consent

Exclusion Criteria:

• The patient has a known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDS (prescription or over-the-counter)
• The patient has received an investigational drug or used an investigational device within 30 days prior to entering the trial
• In the opinion of the investigator the patient has any disease or condition that may result in altered absorption, excess accumulation or impaired metabolism or excretion of the trial medication
• The patient has a history of recurrent peptic ulcer or history (within the past 6 months) of gastrointestinal perforation, peptic ulceration documented by endoscopy or radiography, symptomatic hiatal hernia requiring daily treatment or any history of a gastrointestinal tract hemorrhage, except simple hemorrhoidal bleeding
• The patient is currently on coumadin or might be placed on coumadin during the course of the clinical trial
• Patients with dementia, i.e. incapable of following directions or complying with the study protocol
• Patients with co-existing rheumatological disorders including rheumatoid arthritis
• The patient has previously participated in this trial
• Patients with coexisting fibromyalgia or ankylosing spondylitis
• Patient is pregnant or lactating
• Patient has severe hepatic failure
• Patient has non-dialysed renal failure
• Patient has history of GI bleed within the past 6 months
• Patient has history of cerebrovascular bleeding or other bleeding disorders
• Patient is receiving concomitant lithium, heparin or ticlopidine therapy
• Patient has a history of leukopenia (White Blood Cell count < 3500/mm³)
• The patient has a history of platelet count below the lower limit of normal or has a documented abnormal prothrombin time (PT) or partial thromboplastin time (PTT)