CompletedPhase 3

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

United States768 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria include: * Moderate to severe acute pain for which parenteral opioid therapy is warranted * Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure. Exclusion Criteria include: * Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that would confound the interpretation of safety, tolerability, or efficacy data in the study. * Hemodynamic instability or respiratory insufficiency. * Advanced cancer in palliative or end-of-life care. * Another current painful condition (other than acute pain for which parenteral opioid therapy is warranted) that would confound the interpretation of safety, tolerability, or efficacy data in the study. * Clinically significant, immune-mediated hypersensitivity reaction to opioids.

What they're measuring

Number of Patients That Experienced a Treatment-emergent Adverse Event

Timeframe: From first dose through 3 days after last dose, approximately 4 days

Trial details

NCT IDNCT02656875

SponsorTrevena Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2020-08-24

View on ClinicalTrials.gov More Acute Pain trials