Status:
COMPLETED
A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Joint Diseases
Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous b...
Detailed Description
Chronic pain from end-stage degenerative joint disease is often moderate to severe in intensity and results in a relatively constant level of pain requiring continuous pain relief medication. Despite ...
Eligibility Criteria
Inclusion
- A clinical diagnosis of osteoarthritis of the hip or knee
- End-stage degenerative joint disease
- Eligibility for primary unilateral total or partial joint replacement surgery
- Pain level moderate to severe and at such a level as to require daily doses of an opioid analgesic medication
Exclusion
- Has a life-long history of seizure disorder or epilepsy
- Had any of the following within the preceding 1 year: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
- Had a severe traumatic brain injury within 15 years of screening (consisting of one or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting for more than 24 hours)
- Joint pain not associated with gout, fibromyalgia, rheumatoid arthritis, other autoimmune disease
- History of alcohol or drug abuse
- chronic hepatitis B and C or HIV, active hepatitis B and C within 3 months
- Severely impaired renal function or moderately to severely impaired hepatic function
- History of cancer within past 2 years
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
597 Patients enrolled
Trial Details
Trial ID
NCT00784277
Start Date
October 1 2008
End Date
July 1 2009
Last Update
February 13 2012
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