Status:
COMPLETED
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Arthralgia
Bunion
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with p...
Detailed Description
Patients undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioi...
Eligibility Criteria
Inclusion
- Patients must undergo primary unilateral first metatarsal bunionectomy
- Pain intensity must be moderate to severe following removal of a continuous popliteal sciatic block
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active.
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 severe renal insufficiency
- Moderately or severely impaired hepatic function
- Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
901 Patients enrolled
Trial Details
Trial ID
NCT00613938
Start Date
February 1 2008
End Date
October 1 2008
Last Update
May 9 2014
Active Locations (7)
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1
Glendale, California, United States
2
Pasadena, Maryland, United States
3
Austin, Texas, United States
4
Houston, Texas, United States