Status:
COMPLETED
A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
Lead Sponsor:
Abbott
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00402792
Start Date
December 1 2006
End Date
April 1 2007
Last Update
January 25 2011
Active Locations (5)
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1
Site Ref # / Investigator 2589
Austin, Texas, United States, 78705
2
Site Ref # / Investigator 2587
Houston, Texas, United States, 77081
3
Site Ref # / Investigator 2586
San Antonio, Texas, United States, 78229
4
Site Ref # / Investigator 2588
San Marcos, Texas, United States, 78666