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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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 bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Grünenthal GmbH
• Treatments: Oxycodone; Tapentadol

Criteria

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

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 moderately to severely impaired hepatic function

• History of cancer within past 2 years