Status:
COMPLETED
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With 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:
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 3 different dose levels of CG5503 compared with oxycodone and with placebo in pat...
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 stoppage of a continuous popliteal sciatic block (a nerve block with local anesthetic that numbs the foot)
- 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 moderate or severe renal insufficiency
- currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT00364247
End Date
May 1 2007
Last Update
June 9 2011
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