CompletedNCT00404391Updated Jan 19, 2011

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

A Phase 2 interventional study of Hydrocodone/Acetaminophen Extended Release and Hydrocodone/Acetaminophen Extended Release in Pain, sponsored by Abbott. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-01-19.

Sponsored by Abbott · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 210
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Pain

Keywords

Moderate to severe pain following bunionectomy surgery

In context

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 210 participants (actual)

Study arms

Experimental
Arm 1: hydrocodone/acetaminophen extended release
Drug: Hydrocodone/Acetaminophen Extended Release
Experimental
Arm 2: hydrocodone/acetaminophen extended release
Drug: Hydrocodone/Acetaminophen Extended Release
Placebo comparator
placebo
Drug: Placebo

Interventions

DrugHydrocodone/Acetaminophen Extended Release
1 tablet every 12 hours
Also known as: ABT-712
DrugHydrocodone/Acetaminophen Extended Release
2 tablets every 12 hours
Also known as: ABT-712
DrugPlacebo
2 tablets every 12 hours

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

4 sites

Site Ref # / Investigator 4993
Owing Mills, Maryland 21117, United States
Site Ref # / Investigator 4994
Austin, Texas 78705, United States
Site Ref # / Investigator 4992
San Marcos, Texas 78666, United States
Site Ref # / Investigator 4995
Salt Lake City, Utah 84117, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00404391
Lead sponsor: Abbott
First posted: Nov 28, 2006
Start date: Oct 2003
Primary completion: Mar 2004
Completion: Mar 2004
Last update: Jan 19, 2011

Study contacts

Rita Jain, MD

study director · Abbott

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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