A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
Arthroplasty
About this trial
This is an interventional treatment trial for Arthroplasty focused on measuring Arthralgia, Pain, Pain Assessment, Hip Replacement, Tapentadol
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection) Baseline pain intensity >= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study Exclusion Criteria: Patients will be excluded from the study if they have a history of seizure disorder or epilepsy history of malignancy within the past 2 years before starting the study history of alcohol or drug abuse evidence of active infections that may spread to other areas of the body clinical laboratory values reflecting moderate or severe kidney insufficiency currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI), (selective serotonin reuptake inhibitor [SSRI] treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Experimental
Other
003
002
001
004
Placebo Fixed Dose Matching placebo for 3 days
Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days
Tapentadol IR (CG5503) Fixed Dose 50, 75, & 100 mg BID for 3 days
Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days