A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery
Phase 2
Completed
- Conditions
- Pain
- Interventions
- Drug: Placebo
- Registration Number
- NCT00404391
- 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 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: hydrocodone/acetaminophen extended release Hydrocodone/Acetaminophen Extended Release - Arm 2: hydrocodone/acetaminophen extended release Hydrocodone/Acetaminophen Extended Release - placebo Placebo -
- Primary Outcome Measures
Name Time Method Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration 12 hours Pain relief measured by a 100mm Visual Analog Scale (VAS)
- Secondary Outcome Measures
Name Time Method Time interval weighted sum of pain intensity difference (SPID)scores 12 hours Sum of pain intensity difference
Trial Locations
- Locations (4)
Site Ref # / Investigator 4993
🇺🇸Owing Mills, Maryland, United States
Site Ref # / Investigator 4994
🇺🇸Austin, Texas, United States
Site Ref # / Investigator 4995
🇺🇸Salt Lake City, Utah, United States
Site Ref # / Investigator 4992
🇺🇸San Marcos, Texas, United States