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
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 pain
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedStudy Start
First participant enrolled
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2015
CompletedResults Posted
Study results publicly available
September 7, 2020
CompletedSeptember 7, 2020
August 1, 2020
3 days
August 7, 2015
August 18, 2020
August 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
3-hours
Secondary Outcomes (3)
Time Weighted Average Change in NPRS
From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours
Time to First NPRS <= 3
3-hours
Safety Assessments
3-hours
Study Arms (1)
TRV130
EXPERIMENTALDrug: TRV130
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trevena Inc.lead
- Kestrel Biologiccollaborator
Study Sites (1)
Trevena, Inc.
Indianapolis, Indiana, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study terminated early due to lack of enrollment. Analyses for the primary and secondary outcomes were not completed. No mortalities, serious adverse events, or adverse events were reported.
Results Point of Contact
- Title
- Kelly Arscott
- Organization
- Trevena, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Indiana University
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 11, 2015
Study Start
October 20, 2015
Primary Completion
October 23, 2015
Study Completion
October 23, 2015
Last Updated
September 7, 2020
Results First Posted
September 7, 2020
Record last verified: 2020-08