A Pilot Study of TRV130 for the Treatment of Fracture Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-20

Study Completion Date

2015-10-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRV130

Drug: TRV130

Group Type EXPERIMENTAL

TRV130

Intervention Type DRUG

Drug

Interventions

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TRV130

Drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No