A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
Completed · Phase 3 · Has a placebo group
Conditions studied: Pain
In brief
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
Key facts
- Study ID
- NCT00402792
- Run by
- Abbott
- People needed
- 150
- Starts
- 2006-12-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2011-01-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females ages 18 to 65
- 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
You may not qualify if…
- Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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