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

A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404391

Enrollment

210

Registered

2006-11-28

Start date

2003-10-31

Completion date

2004-03-31

Last updated

2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Moderate to severe pain following bunionectomy surgery

Brief 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.

Interventions

DRUGHydrocodone/Acetaminophen Extended Release

1 tablet every 12 hours

DRUGPlacebo

2 tablets every 12 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration	12 hours	Pain relief measured by a 100mm Visual Analog Scale (VAS)

Secondary

Measure	Time frame	Description
Time interval weighted sum of pain intensity difference (SPID)scores	12 hours	Sum of pain intensity difference

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026