A Study of TRV130 for the Treatment of Pain After Bunionectomy

NCT02100748 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2020-09-16

Study results available
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Summary

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

Conditions

  • Acute Pain

Interventions

DRUG

TRV130

TRV130 1 - 4 mg will be administered every 4 hours

DRUG

Morphine

Morphine 4 mg will be administered every 4 hours

DRUG

Placebo

Placebo will be administered every 4 hours

Sponsors & Collaborators

  • Trevena Inc.

    lead INDUSTRY

Principal Investigators

  • Franck Skobieranda, MD · Trevena Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100748 on ClinicalTrials.gov