Status:
COMPLETED
Bunionectomy Trial With GRT6005
Lead Sponsor:
Tris Pharma, Inc.
Conditions:
Post Operative Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00872885
Start Date
March 1 2009
End Date
October 1 2009
Last Update
July 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Premier Research Group Ltd
Austin, Texas, United States, 78705