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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Meloxicam

Drug: NSAID

Study type

Interventional

Funder types

Industry

Identifiers

NCT02183064

107.210

Details and patient eligibility

About

Study to compare the percentage of treatment successes or failures in patients randomized to meloxicam 7.5 mg vs. usual care prescription NSAIDs. Additionally, health care utilization, efficacy and safety of patients in a managed healthcare setting with osteoarthritis (OA) of the hip, knee, hand or spine will be assessed.

Enrollment

1,309 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)