A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy

Abbott5 sites in 1 country150 target enrollmentDecember 2006

ConditionsPain

InterventionsHydrocodone/Acetaminophen Extended-Release Hydrocodone/Acetaminophen Extended Release Placebo

DrugsHydrocodone/Acetaminophen Extended-Release Hydrocodone/Acetaminophen Extended Release Placebo

Overview

Phase: Phase 3
Intervention: Hydrocodone/Acetaminophen Extended-Release
Conditions: Pain
Sponsor: Abbott
Enrollment: 150
Locations: 5
Primary Endpoint: Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

April 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

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

Arms & Interventions

Arm 1: hydrocodone / acetaminophen extended release

Intervention: Hydrocodone/Acetaminophen Extended-Release

Arm 2: hydrocodone / acetaminophen extended release

Intervention: Hydrocodone/Acetaminophen Extended Release

Arm 3: Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration.

Time Frame: 12 hours

Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)

Secondary Outcomes

Perceptible pain relief(12 hours)
Meaningful pain relief(12 hours)
Pain relief (PR)(12 hours)
Pain intensity (PI)(12 hours)
Time-interval weighted sum of pain relief (TOTPAR)(12 hours)
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)(12 hours)