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
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:
GrĂ¼nenthal 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).