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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00404391

Run by

Abbott

People needed

210

Starts

2003-10-01

Expected to finish

2004-03-01

Last updated by the study team

2011-01-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Ref # / Investigator 4993 — Owing Mills, Maryland, United States
• Site Ref # / Investigator 4994 — Austin, Texas, United States
• Site Ref # / Investigator 4992 — San Marcos, Texas, United States
• Site Ref # / Investigator 4995 — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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