A Pilot Study of TRV130 for the Treatment of Fracture Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02520297
• Other study ID #: CP130-2004
• Status: Terminated
• Phase: Phase 2
• Start date: October 20, 2015
• Est. completion date: October 23, 2015

Study information

• Verified date: August 2020
• Source: Trevena Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 23, 2015
• Est. primary completion date: October 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Pain

Intervention

Drug:
• TRV130
Drug

Locations

Country	Name	City	State
United States	Trevena, Inc.	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Trevena Inc.	Kestrel Biologic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time Weighted Average Change in NPRS	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
Secondary	Time to First NPRS <= 3	Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours	3-hours
Secondary	Safety Assessments	Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.	3-hours