Intravenous Tapentadol in Post-Bunionectomy Pain

Launched by GRÜNENTHAL GMBH · Sep 15, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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