Status:
COMPLETED
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
Lead Sponsor:
Abbott
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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/Acet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00404222
Start Date
November 1 2005
End Date
February 1 2006
Last Update
July 25 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.