A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Hydrocodone/Acetaminophen Extended Release; Drug: Placebo; Drug: Hydrocodone/Acetaminophen Extended-Release

• Registration Number: NCT00402792
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Study Start: 2006-12
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: hydrocodone / acetaminophen extended release	Hydrocodone/Acetaminophen Extended Release	-
Arm 3: Placebo	Placebo	-
Arm 1: hydrocodone / acetaminophen extended release	Hydrocodone/Acetaminophen Extended-Release	-

Primary Outcome Measures

Name	Time	Method
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.	12 hours	Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Perceptible pain relief	12 hours
Meaningful pain relief	12 hours
Pain relief (PR)	12 hours
Pain intensity (PI)	12 hours
Time-interval weighted sum of pain relief (TOTPAR)	12 hours
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)	12 hours

Trial Locations

Locations (5)

Site Ref # / Investigator 2587; 🇺🇸 Houston, Texas, United States

Site Ref # / Investigator 2588; 🇺🇸 San Marcos, Texas, United States

Site Ref # / Investigator 2586; 🇺🇸 San Antonio, Texas, United States

Site Ref # / Investigator 2589; 🇺🇸 Austin, Texas, United States

Site Ref # / Investigator 2585; 🇺🇸 Salt Lake City, Utah, United States