A Pilot Study of TRV130 for the Treatment of Fracture Pain

Phase 2

Terminated

• Conditions: Pain
• Interventions: Drug: TRV130

• Registration Number: NCT02520297
• Lead Sponsor: Trevena Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-11
• Study Start: 2015-10-20
• Primary Completion: 2015-10-23
• Study Completion: 2015-10-23
• Disposition First Submitted: 2017-07-07
• Disposition First Submitted QC: 2017-07-07
• Disposition First Posted: 2017-07-11
• Status Verified: 2020-08
• Results First Submitted: 2020-08-18
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-09-07
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRV130	TRV130	Drug: TRV130

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.	3-hours	Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Secondary Outcome Measures

Name	Time	Method
Time Weighted Average Change in NPRS	From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours	Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Time to First NPRS <= 3	3-hours	Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Safety Assessments	3-hours	Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.

Trial Locations

Locations (1)

Trevena, Inc.; 🇺🇸 Indianapolis, Indiana, United States