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

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Hydrocodone/Acetaminophen Extended-Release; Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®); Drug: Placebo

• Registration Number: NCT00404222
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-11-26
• Study First Submitted QC: 2006-11-26
• Study First Posted: 2006-11-28
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-22
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydrocodone / acetaminophen extended release	Hydrocodone/Acetaminophen Extended-Release	-
Hydrocodone/Acetaminophen Immediate Release (Norco ®)	Hydrocodone/Acetaminophen Immediate Release (NORCO®)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Time-interval weighted sum of pain relief (TOTPAR)	12 hours
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)	12 hours