A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis
NCT ID: NCT00404183
Last Updated: 2011-01-19
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
120 participants
INTERVENTIONAL
2004-08-31
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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hydrocodone/acetaminophen extended release
Extended-Release Hydrocodone/Acetaminophen
2 tablets BID
Placebo
Placebo
2 tablets BID
Interventions
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Extended-Release Hydrocodone/Acetaminophen
2 tablets BID
Placebo
2 tablets BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has osteoarthritis of the hip or knee
* Requires therapeutic doses of medications for osteoarthritis
* If female, must be of non-childbearing potential or practicing birth control
* Has sufficient pain to justify the use of round-the-clock opioids
Exclusion Criteria
* Has certain medical conditions which may interfere with pain assessments
* Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
* Has had certain infections, injuries or illnesses within the last month
* Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
* Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
* Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
* Cannot discontinue pain medications, even for a short time, prior to the study start
21 Years
75 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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M03-643
Identifier Type: -
Identifier Source: org_study_id
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