A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy

Abbott

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: Hydrocodone/Acetaminophen Extended Release

Drug: Placebo

Drug: Hydrocodone/Acetaminophen Extended-Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00402792

M05-765

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 compared to 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.

Enrollment

150 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females ages 18 to 65
Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
Meet specific pain intensity criteria on the morning after surgery
Willing to be confined for 4 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, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract
Has specific active or uncontrolled seizure disorders
Has been diagnosed with certain cancers within the past 5 years
Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression
Has specific clinically significant illnesses or laboratory abnormalities
Has received corticosteroid treatment or any investigational drug within a specific timeframe