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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404222

Enrollment

Registered

2006-11-28

Start date

2005-11-30

Completion date

2006-02-28

Last updated

2011-07-25

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

Conditions

Pain

Keywords

Acute Pain following Bunionectomy

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.

Interventions

DRUGHydrocodone/Acetaminophen Extended-Release

2 tablets x 1

DRUGHydrocodone/Acetaminophen Immediate Release (NORCO®)

1 tablet q 4 hours x 3

DRUGPlacebo

q 4 hours x 3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	12 hours
Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)	12 hours

Secondary

Measure	Time frame
Time to first noticeable pain relief (i.e., onset of pain relief)	12 hours
Time-interval weighted sum of pain relief (TOTPAR)	12 hours
Proportion of subjects experiencing meaningful pain relief after dosing	12 hours
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)	12 hours
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)	12 hours

Outcome results

None listed

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