Overview

A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (VicodinĀ® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abbott
Treatments:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Analgesics
Hydrocodone
Oxycodone
Polystyrene sulfonic acid
Criteria
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