NCT02656875

A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain

A Phase 3, Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain for Which Parenteral Opioid Therapy is Warranted

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 768 (actual)
• Sponsor: Trevena Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined by the investigator, for a duration not to exceed 14 days.

Detailed description

The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. Eligible patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA administration, or both, as determined by the investigator, for a duration not to exceed 14 days. The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. A follow-up assessment will take place 2-3 days after the completion of the treatment phase.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	TRV130

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2016-01-15
• Last updated: 2020-09-24
• Results posted: 2020-09-24

Locations

10 sites across 1 country: United States