A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

Abbott90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

Hydrocodone/Acetaminophen Extended-ReleaseDRUG

2 tablets x 1

Hydrocodone/Acetaminophen Immediate Release (NORCO®)DRUG

1 tablet q 4 hours x 3

PlaceboDRUG

q 4 hours x 3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

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-interval weighted sum of pain relief (TOTPAR)

Time frame: 12 hours

Time-interval weighted sum of pain relief and pain intensity difference (SPRID)

Time frame: 12 hours

Time to first noticeable pain relief (i.e., onset of pain relief)

Time frame: 12 hours

Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)

Time frame: 12 hours

Proportion of subjects experiencing meaningful pain relief after dosing

Time frame: 12 hours

Data from ClinicalTrials.gov

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