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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam | Experimental |
| |
| Usual care prescription NSAID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug |
| ||
| NSAID |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of treatment successes and failures in patients randomized to meloxicam 7.5 mg vs.usual care prescription NSAIDs | up to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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|
| 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 |
| Western Ontario and Mc Master University Osteoarthritis Index (WOMAC) | Day 0, 30, 60, 90, 120, 150, 180 |
| Medication Compliance | Day 30, day 180 |
| Disability Index | Screening (Day 0), after six month (Day 180) |
| Permanent Discontinuation of Study Medication related to lack of efficacy | up to day 180 |
| Incidence and intensity of adverse events | from day 30 until day 180 |
| Permanent Discontinuation of Study Medication related to adverse event | from day 30 until day 180 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
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