Bunionectomy Trial With GRT6005 (NCT00872885) | Clinical Trial Compass
CompletedPhase 2
Bunionectomy Trial With GRT6005
United States258 participantsStarted 2009-03
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments