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To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg administered in a single dose, over an observation period of 6 hours in the treatment of pain after surgery of the third molar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam 15 mg | Experimental |
| |
| Meloxicam 7.5 mg | Experimental |
| |
| Meloxicam 3.75 mg | Experimental |
| |
| Meloxicam 1.875 mg | Experimental |
| |
| Ibuprofen 400 mg | Active Comparator |
| |
| Ibuprofen 200 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam 7.5 mg | Drug |
| ||
| Meloxicam 3.75 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pain intensity differences (PID) on a visual analogue scale (VAS, 100 mm) from one hour onwards | 60, 90, 120, 180, 240, 300 and 360 minutes after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PID on a VAS | Up to 360 minutes after drug administration | |
| Sum of pain intensity differences (SPID) | Up to 360 minutes after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Meloxicam 1.875 mg | Drug |
|
| Ibuprofen 200 mg | Drug |
|
| Placebo | Drug |
|
| Meloxicam 15 mg | Drug |
|
| Ibuprofen 400 mg | Drug |
|
| Number of patients with pain decrease >=50% |
| Up to 360 minutes after drug administration |
| Assessment of maximum pain decrease on a VAS | Up to 360 minutes after drug administration |
| Number of withdrawals due to safety reasons | Up to 7 days after drug administration |
| Number, nature and severity of adverse events | Up to 7 days after drug administration |
| Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve) | Up to 360 minutes after drug administration |
| Assessment of onset of analgesic action | Up to 2 hours after surgery |
| Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS) | 6 hours after drug administration |
| Final assessment of efficacy by investigator on a 4-point VRS | 2 hours after drug administration |
| Change from baseline in laboratory values | Baseline, up to 7 days after drug administration |
| Assessment of the progress of healing of the extraction site | 3-7 days after drug administration |
| Patient's assessment of overall tolerability on a 4-point rating scale | Day 7 after drug administration |
| Investigator's assessment of overall tolerability on a 4-point rating scale | Day 7 after drug administration |
| Pain relief assessed by patient on a 5-point VRS | Up to 360 minutesafter drug administration |
| Number of withdrawals due to inadequate efficacy | Up to 7 days after drug administration |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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