Overview

A Pilot Study of TRV130 for the Treatment of Fracture Pain

Status:
Terminated
Trial end date:
2015-10-23
Target enrollment:
0
Participant gender:
All
Summary
The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Trevena Inc.
Collaborator:
Kestrel Biologic
Criteria
Inclusion Criteria:

- Age 18-65 years, inclusive

- Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both)
OR tibia, fibula (or both) BUT not fractures in more than 1 extremity

- Able to understand and comply with study procedures and requirements, and provide
written informed consent

Exclusion Criteria:

- Significant concomitant head, chest, or abdominal trauma

- Multiple extremity trauma

- Open fracture

- Clinically significant medical condition or history of such condition that may place
the patient at an unacceptable risk in the trial, may interfere with the
interpretation of efficacy, safety, or tolerability data obtained in the trial, or may
interfere with the absorption, distribution, metabolism, or excretion of drugs