Bunionectomy Trial With GRT6005

A Randomized, Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Moderate to Severe Pain Following Bunionectomy.

The purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).

Inclusion Criteria:

• Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy

Exclusion Criteria:

• Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
• Concomitant inflammatory disease.
• Life-long history of seizure disorder or epilepsy.
• Subjects with impaired renal function
• Subjects with impaired hepatic function
• Female subjects who are pregnant or breastfeeding.
• Resting pulse rate is <50bpm or >100 bpm after 5 minutes rest in supine position
• resting blood pressure after 5 minutes rest in supine position: Systolic blood pressure is <100mmHg or >140 mmHg Diastolic blood pressure is <60 mmHg or > 90 mmHg