Overview
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.
Status:
Completed
Completed
Trial end date:
2007-05-01
2007-05-01
Target enrollment:
0
0
Participant gender:
All
All
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 patients who have had a bunionectomy, and to assess the safety of the drug for 9 days after patients are discharged from the hospital.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Collaborator:
GrĂ¼nenthal GmbHTreatments:
Tapentadol
Criteria
Inclusion Criteria:- 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 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 renal insufficiency
- currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs),
tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake
inhibitor (SNRI).