A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
NCT ID: NCT00404222
Last Updated: 2011-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2005-11-30
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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hydrocodone / acetaminophen extended release
Hydrocodone/Acetaminophen Extended-Release
2 tablets x 1
Hydrocodone/Acetaminophen Immediate Release (Norco ®)
Hydrocodone/Acetaminophen Immediate Release (NORCO®)
1 tablet q 4 hours x 3
Placebo
Placebo
q 4 hours x 3
Interventions
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Hydrocodone/Acetaminophen Extended-Release
2 tablets x 1
Hydrocodone/Acetaminophen Immediate Release (NORCO®)
1 tablet q 4 hours x 3
Placebo
q 4 hours x 3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Rita Jain, MD
Role: STUDY_DIRECTOR
Abbott
Other Identifiers
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M05-772
Identifier Type: -
Identifier Source: org_study_id
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