Intravenous Tapentadol in Post-Bunionectomy Pain

A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.

The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.

Inclusion Criteria:

• Scheduled to undergo primary unilateral first metatarsal bunionectomy
• Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
• Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).

Exclusion Criteria:

• History of malignancy within the past 2 years
• Current or history of alcohol or drug abuse.
• Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
• History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
• Severely impaired renal function
• Moderately or severely impaired hepatic function
• Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
• Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication