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The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, 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 |
|---|---|---|---|
| Arm 1: hydrocodone/acetaminophen extended release | Experimental |
| |
| Arm 2: hydrocodone/acetaminophen extended release | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocodone/Acetaminophen Extended Release | Drug | 1 tablet every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration | Pain relief measured by a 100mm Visual Analog Scale (VAS) | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time interval weighted sum of pain intensity difference (SPID)scores | Sum of pain intensity difference | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Jain, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 4993 | Owing Mills | Maryland | 21117 | United States | ||
| Site Ref # / Investigator 4994 |
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| Hydrocodone/Acetaminophen Extended Release | Drug | 2 tablets every 12 hours |
|
|
| Placebo | Drug | 2 tablets every 12 hours |
|
| Austin |
| Texas |
| 78705 |
| United States |
| Site Ref # / Investigator 4992 | San Marcos | Texas | 78666 | United States |
| Site Ref # / Investigator 4995 | Salt Lake City | Utah | 84117 | United States |
| 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 |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| 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 |
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