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.

Tris Pharma, Inc.1 site in 1 country258 target enrollmentMarch 2009

ConditionsPost Operative Pain

InterventionsGRT6005 Morphine Placebo

DrugsGRT6005 Morphine Placebo

Overview

Phase: Phase 2
Intervention: GRT6005
Conditions: Post Operative Pain
Sponsor: Tris Pharma, Inc.
Enrollment: 258
Locations: 1
Primary Endpoint: Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

October 2009

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tris Pharma, Inc.

Responsible Party

Sponsor

Eligibility 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