Phase 3
N=768
A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02656875 ↗Enrolled (actual)
768
Serious AEs
3.4%
Results posted
Sep 2020
Primary outcome: Primary: Number of Patients That Experienced a Treatment-emergent Adverse Event — 490 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TRV130 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trevena Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Experienced a Treatment-emergent Adverse Event |
490 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02656875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.