Title
A Pilot Study of TRV130 for the Treatment of Fracture Pain
A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture
Phase
Phase 2Lead Sponsor
Trevena Inc.Study Type
InterventionalStatus
Terminated Results PostedIndication/Condition
PainIntervention/Treatment
oliceridine ...Study Participants
1The 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.
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.
Drug
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
| Event Type | Organ System | Event Term |
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Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.
