Bunionectomy Trial With GRT6005

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH; Tris Pharma, Inc.
• Treatments: Analgesics; Morphine

Criteria

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