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
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Grünenthal GmbH
• Treatments: 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).