A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
NCT ID: NCT00402792
Last Updated: 2011-01-25
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
PHASE3
150 participants
INTERVENTIONAL
2006-12-31
2007-04-30
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
DOUBLE
Study Groups
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Arm 1: hydrocodone / acetaminophen extended release
Hydrocodone/Acetaminophen Extended-Release
1 tablet q 12 hours
Arm 2: hydrocodone / acetaminophen extended release
Hydrocodone/Acetaminophen Extended Release
2 tablets q 12 hours
Arm 3: Placebo
Placebo
2 tablets q 12 hours
Interventions
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Hydrocodone/Acetaminophen Extended-Release
1 tablet q 12 hours
Hydrocodone/Acetaminophen Extended Release
2 tablets q 12 hours
Placebo
2 tablets q 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
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
Locations
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Site Ref # / Investigator 2589
Austin, Texas, United States
Site Ref # / Investigator 2587
Houston, Texas, United States
Site Ref # / Investigator 2586
San Antonio, Texas, United States
Site Ref # / Investigator 2588
San Marcos, Texas, United States
Site Ref # / Investigator 2585
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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M05-765
Identifier Type: -
Identifier Source: org_study_id
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