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The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrocodone / acetaminophen extended release | Experimental |
| |
| Hydrocodone/Acetaminophen Immediate Release (Norco ®) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocodone/Acetaminophen Extended-Release | Drug | 2 tablets x 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration. | 12 hours | |
| Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS) | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time-interval weighted sum of pain relief (TOTPAR) | 12 hours | |
| Time-interval weighted sum of pain relief and pain intensity difference (SPRID) | 12 hours | |
| Time to first noticeable pain relief (i.e., onset of pain relief) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Jain, MD | Abbott | Study Director |
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| 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 |
|---|---|
| D006853 | Hydrocodone |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Hydrocodone/Acetaminophen Immediate Release (NORCO®) | Drug | 1 tablet q 4 hours x 3 |
|
| Placebo | Drug | q 4 hours x 3 |
|
| 12 hours |
| Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline) | 12 hours |
| Proportion of subjects experiencing meaningful pain relief after dosing | 12 hours |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |