A Pilot Study of TRV130 for the Treatment of Fracture Pain

August 18, 2020 updated by: Trevena Inc.

A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRV130
Drug: TRV130
Drug: TRV130
Drug

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trevena Inc.

Collaborators

Kestrel Biologic

Investigators

  • Principal Investigator: Indiana University, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2015

Primary Completion (Actual)

October 23, 2015

Study Completion (Actual)

October 23, 2015

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP130-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on TRV130

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe