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

Abbott0 sites90 target enrollmentNovember 2005

ConditionsPain

InterventionsHydrocodone/Acetaminophen Extended-Release Hydrocodone/Acetaminophen Immediate Release (NORCO®)Placebo

DrugsPlacebo Hydrocodone/Acetaminophen Extended-Release Hydrocodone/Acetaminophen Immediate Release (NORCO®)

Overview

Phase: Phase 2
Intervention: Hydrocodone/Acetaminophen Extended-Release
Conditions: Pain
Sponsor: Abbott
Enrollment: 90
Primary Endpoint: The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes 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 and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

February 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

Inclusion Criteria

•Males and females ages 18 to 65
•Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
•Must meet specific pain intensity criteria on the morning after surgery
•Willing to remain at the study center 2 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, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
•Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
•Has a history of or currently has any active seizure disorder
•Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
•Has been diagnosed with cancer within the past 3 years
•Requires treatment with certain drugs for depression or psychiatric disorders
•Has specific clinically significant illnesses or laboratory abnormalities
•Received corticosteroid treatment or any investigational drug within a specific timeframe.

Arms & Interventions

hydrocodone / acetaminophen extended release

Intervention: Hydrocodone/Acetaminophen Extended-Release

Hydrocodone/Acetaminophen Immediate Release (Norco ®)

Intervention: Hydrocodone/Acetaminophen Immediate Release (NORCO®)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.

Time Frame: 12 hours

Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)

Time Frame: 12 hours

Secondary Outcomes

Time to first noticeable pain relief (i.e., onset of pain relief)(12 hours)
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)(12 hours)
Proportion of subjects experiencing meaningful pain relief after dosing(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)