Status:
COMPLETED
A Study of Pain Relief in Osteoarthritis
Lead Sponsor:
Abbott
Conditions:
Osteoarthritis
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.
Eligibility Criteria
Inclusion
- Males and females ages 21 to 80
- If female, must be of non-child bearing potential or practicing birth control
- Has osteoarthritis of the hip or knee
- Requires therapeutic doses of medication for osteoarthritis pain
- Has sufficient pain to justify the use of around-the-clock opioids
Exclusion
- Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
- Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
- Cannot discontinue pain medications, even for the short time prior to the study start
- Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
- Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
- Has a history of malnutrition or starvation
- Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
- Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
- Pregnant or breastfeeding females
- Is incapacitated, bedridden or confined to a wheelchair
- Has initiated any new therapy or medication for OA within 1 month of screening
- Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
- Has other conditions that may cause pain, such as rheumatoid arthritis or gout
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
873 Patients enrolled
Trial Details
Trial ID
NCT00298974
Start Date
February 1 2006
End Date
May 1 2007
Last Update
January 25 2011
Active Locations (83)
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1
Site Ref # / Investigator 423
Birmingham, Alabama, United States, 35235
2
Site Ref # / Investigator 581
Birmingham, Alabama, United States, 35235
3
Site Ref # / Investigator 459
Birmingham, Alabama, United States, 35244
4
Site Ref # / Investigator 580
Mobile, Alabama, United States, 36608