Status:
COMPLETED
A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery
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 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placeb...
Eligibility Criteria
Inclusion
- Male or female ages 18 to 65
- Females must be of non-childbearing potential or practicing birth control
- Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
Exclusion
- Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
- Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
- Is associated with any currently ongoing research study
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00404391
Start Date
October 1 2003
End Date
March 1 2004
Last Update
January 19 2011
Active Locations (4)
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1
Site Ref # / Investigator 4993
Owing Mills, Maryland, United States, 21117
2
Site Ref # / Investigator 4994
Austin, Texas, United States, 78705
3
Site Ref # / Investigator 4992
San Marcos, Texas, United States, 78666
4
Site Ref # / Investigator 4995
Salt Lake City, Utah, United States, 84117