Status:
COMPLETED
A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis
Lead Sponsor:
Abbott
Conditions:
Pain
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
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 with placebo over a 5-week dosing peri...
Eligibility Criteria
Inclusion
- Males or females ages 21 to 75
- 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
- Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00404183
Start Date
August 1 2004
Last Update
January 19 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.