A Pilot Study of TRV130 for the Treatment of Fracture Pain

Trevena

Status and phase

Terminated

Phase 2

Conditions

Pain

Treatments

Drug: TRV130

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02520297

CP130-2004

Details and patient eligibility

About

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.

Full description

This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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