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Therapeutic Areas: Rheumatology
Disease Category: Arthritis and Arthritic Pain
Trial Information
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
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 bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled patients.
Patient Inclusion Criteria:
- 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
Patient Exclusion Criteria:
- 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 moderaetly to severely impaired hepatic function
- History of cancer within past 2 years.
Kelly Colucci, Manager, Grants and Contracts
Atlantic Health System
475 South Street
Morristown, NJ 07962
Phone: 973-660-3139
EMail: kelly.colucci@atlantichealth.org
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Research Center Information: Atlantic Health System
If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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