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

Abbott

Status and phase

Completed

Phase 2

Conditions

Pain

Treatments

Drug: Hydrocodone/Acetaminophen Extended-Release

Drug: Placebo

Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00404222

M05-772

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.