A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery

Detailed Description
-----------------
Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: 10 mg HC-ER
* Drug: 20 mg HC-ER
* Drug: 30 mg HC-ER
* Drug: 40 mg HC-ER
* Drug: 10 mg HC / 325 mg APAP
* Drug: Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was able to read and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document and given the opportunity to ask questions regarding the study prior to the performance of any study- specific procedures. Subject required primary unilateral first metatarsal bunionectomy surgery with or without hammertoe repair with no other collateral procedures allowed Subject was male or female at least 18 years of age. Subject weighed > or = 100 lbs (pounds). Subject was willing and able to comply with the protocol and able to score their pain intensity. Subject was in good health as determined by the investigator on the basis of medical history, physical examination, Electrocardiogram (ECG) and screening laboratory results. Subject had not developed a condition or complications as result of the bunionectomy procedure that would preclude their participation in the study. Subject was willing and able to remain at the recovery day care center for the entire 24-hour Treatment period. Exclusion Criteria: Subject was pregnant or lactating. Subject had been on an investigational drug within 30 days prior to the initiation of study drug. Subject had donated blood or blood components within one month prior to study (Check-in). Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or ketorolac. Subject had a known history of substance or alcohol abuse within 2 years prior to Screening. Subject tested positive to drug screens (cocaine, marijuana, opioids, benzodiazepines, and barbiturates) that could not be justified by prescription use. Subject had a condition that would contraindicate the use of opioid analgesia (e.g., pulmonary disease or paralytic ileus). Subject had received a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI) carbamazepine, quinidine, and/or tricyclic antidepressants (TCA) compounds within 1-month prior to Check-in. Subject had received opioids, tranquilizers, sedatives, or hypnotics within 48 hours prior to Check-in. Subject had received corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics within 24 hours prior to Check-in.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg HC-ER<br>Hydrocodone bitartrate extended release (HC-ER) 10 mg | Drug: 10 mg HC-ER<br>* Single dose<br>* Other names: Zohydro Extended Release (ER);|
| Experimental: 20 mg HC-ER<br>Hydrocodone bitartrate extended release (HC-ER) 20 mg | Drug: 20 mg HC-ER<br>* Single dose<br>* Other names: Zohydro Extended Release (ER);|
| Experimental: 30 mg HC-ER<br>Hydrocodone bitartrate extended release (HC-ER) 30 mg | Drug: 30 mg HC-ER<br>* Single dose<br>* Other names: Zohydro Extended Release (ER);|
| Experimental: 40 mg HC-ER<br>Hydrocodone bitartrate extended release (HC-ER) 40 mg | Drug: 40 mg HC-ER<br>* Single dose<br>* Other names: Zohydro Extended Release (ER);|
| Active Comparator: 10 mg HC / 325 mg APAP<br>10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP) | Drug: 10 mg HC / 325 mg APAP<br>* Single dose<br>* Other names: 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP);|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Matching Placebo<br>* Single dose<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI) |  | 0-12 hours |