Overview
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
Status:
Completed
Completed
Trial end date:
2006-02-01
2006-02-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AbbottTreatments:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Polystyrene sulfonic acid
Criteria
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.