A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following Bunionectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: Hydrocodone/Acetaminophen Extended-Release
* Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ages 18 to 65 Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy) Must meet specific pain intensity criteria on the morning after surgery Willing to remain at the study center 2 days following surgery If female, must be of non-child bearing potential or practicing birth control Exclusion Criteria: Is allergic to or has a serious reaction to hydrocodone, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) Has a history of or currently has any active seizure disorder Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract Has been diagnosed with cancer within the past 3 years Requires treatment with certain drugs for depression or psychiatric disorders Has specific clinically significant illnesses or laboratory abnormalities Received corticosteroid treatment or any investigational drug within a specific timeframe.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydrocodone / acetaminophen extended release<br> | Drug: Hydrocodone/Acetaminophen Extended-Release<br>* 2 tablets x 1<br>* Other names: hydrocodone / acetaminophen extended release;|
| Active Comparator: Hydrocodone/Acetaminophen Immediate Release (Norco ®)<br> | Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)<br>* 1 tablet q 4 hours x 3<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* q 4 hours x 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pain following Bunionectomy