Status:
COMPLETED
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis
Chronic Pain
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
Detailed Description
The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as ...
Eligibility Criteria
Inclusion
- Subject is 21 years of age or older
- Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
- Negative pregnancy test if female of childbearing potential
- Subject is in general good health
- Subject required treatment of joint pain within the last 90 days
- Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee
Exclusion
- Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
- Subject is pregnant or breast-feeding
- Subject is receiving systemic chemotherapy
- Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
- Subject has history of major depressive disorder not controlled with medication
- Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
- Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
- Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT00420992
Start Date
December 1 2006
End Date
November 1 2007
Last Update
September 20 2013
Active Locations (81)
Enter a location and click search to find clinical trials sorted by distance.
1
The Birmingham Pain Center
Birmingham, Alabama, United States, 35244
2
Horizon Research Group
Mobile, Alabama, United States, 36608
3
Arizona Center for Clinical Research
Peoria, Arizona, United States, 85383
4
Arizona Research Center, Inc
Phoenix, Arizona, United States, 85023