Overview

This trial is active, not recruiting.

Condition acute pain
Treatments oliceridine, placebo, morphine
Phase phase 3
Sponsor Trevena Inc.
Start date May 2016
End date February 2017
Trial identifier NCT02815709, CP130-3001

Summary

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Experimental)
oliceridine
(Experimental)
oliceridine
(Experimental)
oliceridine
(Placebo Comparator)
placebo
(Active Comparator)
morphine

Primary Outcomes

Measure
Proportion of patients who respond to study medication at the 48-hr Numeric Pain Rating Scale (NRS) assessment compared to placebo.
time frame: 48 hours

Secondary Outcomes

Measure
Number of patients with hypoventilation events compared to morphine.
time frame: 48 hours
Duration of hypoventilation events compared to morphine.
time frame: 48 hours
Proportion of patients who respond to study medication at the 48-hr NRS assessment compared to morphine.
time frame: 48 hours
Number of patients with treatment-related adverse events compared to placebo and compared to morphine.
time frame: 48 hours

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. - Experiences a pain intensity rating of moderate to severe acute pain. - Able to provide written informed consent before any study procedure. Exclusion Criteria: - ASA Physical Status Classification System classification of P3 or worse. - Has surgical or post-surgical complications. - Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs. - Has previously participated in another TRV130 clinical study.

Additional Information

Official title A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Trevena Inc..