A Pilot Study of TRV130 for the Treatment of Fracture Pain

Stopped early · Phase 2

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02520297

Run by

Trevena Inc.

People needed

1

Starts

2015-10-20

Expected to finish

2015-10-23

Last updated by the study team

2020-09-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trevena, Inc. — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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