Acute Pain Study Following Bunionectomy

Study Overview
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Brief Summary
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The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

Detailed Description
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The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol. After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Official Title
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A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release 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: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy Exclusion Criteria: Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures Drug allergies to hydrocodone, acetaminophen Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo, 1 oral tablet every 12 hours | Drug: Placebo<br>* Placebo tablet<br>|
| Experimental: Hydrocodone/Acetaminophen Extended Release<br>hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours | Drug: Hydrocodone/Acetaminophen Extended Release<br> <br> * Other names: ABT-712;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) | Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. | From time of first study drug administration to 12 hours following first study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOTPAR (Total Pain Relief) | TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. | From time of first study drug administration to 12 hours following first study drug administration | 
| SPRID (Pain Relief and Pain Intensity Difference) | SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. | From time of first study drug administration to 12 hours following first study drug administration | 
| Time to Perceptible and Meaningful Pain Relief | The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief. | From time of first study drug administration to 12 hours following first study drug administration |