CP130-3003

About this trial

Last updated 5 years ago

Study ID

CP130-3003

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 years ago

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.

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.

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