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

NCT02183064 | Completed Phase 3

• 1 other identifier: 107.210
• Study Type: interventional
• Target: 1,309
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of treatment successes and failures in patients randomized to meloxicam 7.5 mg vs.usual care prescription NSAIDs

  up to 6 month

Secondary Outcomes (11)

• Investigator's Global Assessment of Disease Activity (Likert)

  Screening (Day 0), after six month (Day 180)

• Patient's overall Assessment of pain over the past week on a visual analogue scale (VAS)

  Day 0, 30, 60, 90, 120, 150, 180

• Patient's Assessment of Health Status (VAS)

  Day 0, 30, 60, 90, 120, 150, 180

• Patient's Assessment of Satisfaction of Health

  Day 0, 30, 60, 90, 120, 150, 180

• Utility Index (VAS)

  Day 0, 30, 60, 90, 120, 150, 180

Study Arms (2)

Meloxicam

EXPERIMENTAL

Drug: Meloxicam

Usual care prescription NSAID

ACTIVE COMPARATOR

Drug: NSAID

Interventions

Meloxicam DRUG

Meloxicam

NSAID DRUG

Usual care prescription NSAID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Meloxicam; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: October 1, 1998
• Primary Completion: November 1, 2000
• Last Updated: July 8, 2014

Record last verified: 2014-07