Bunionectomy Trial With GRT6005

Completed · Phase 2 · Has a placebo group

Conditions studied: Post Operative Pain

In brief

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).

Key facts

Study ID

NCT00872885

Run by

Tris Pharma, Inc.

People needed

258

Starts

2009-03-01

Expected to finish

2009-10-01

Last updated by the study team

2021-07-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy

You may not qualify if…

• 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

Where it is running

• Premier Research Group Ltd — Austin, Texas, United States

Full record on ClinicalTrials.gov

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