Status:
TERMINATED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Arthroplasty
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placeb...
Detailed Description
Patients undergoing hip replacement often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, op...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00364533
Start Date
October 1 2006
End Date
December 1 2007
Last Update
April 21 2014
Active Locations (77)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Sheffield, Alabama, United States
4
Phoenix, Arizona, United States