Overview

A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

Status:
Completed
Trial end date:
2006-02-01
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 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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abbott
Treatments:
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.