A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) 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 compared to 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.

Official Title
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A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) 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 Extended Release
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ages 18 to 65 Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery Meet specific pain intensity criteria on the morning after surgery Willing to be confined for 4 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, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract Has specific active or uncontrolled seizure disorders Has been diagnosed with certain cancers within the past 5 years Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression Has specific clinically significant illnesses or laboratory abnormalities Has 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: hydrocodone / acetaminophen extended release<br> | Drug: Hydrocodone/Acetaminophen Extended-Release<br>* 1 tablet q 12 hours<br>* Other names: hydrocodone / acetaminophen extended release;|
| Experimental: Arm 2: hydrocodone / acetaminophen extended release<br> | Drug: Hydrocodone/Acetaminophen Extended Release<br>* 2 tablets q 12 hours<br>* Other names: hydrocodone / acetaminophen extended release;|
| Placebo Comparator: Arm 3: Placebo<br> | Drug: Placebo<br>* 2 tablets q 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration. | Sum of pain intensity difference using a 100 mm 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 | 
| Perceptible pain relief |  | 12 hours | 
| Meaningful pain relief |  | 12 hours | 
| Pain relief (PR) |  | 12 hours | 
| Pain intensity (PI) |  | 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 surgery