A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

• Status: Completed
• Trial end date: 2008-10-01
• 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 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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 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 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).