Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

Phase 3

Completed

• Conditions: Acute Pain
• Interventions: Drug: Oliceridine; Drug: Placebo; Drug: Morphine

• Registration Number: NCT02815709
• Lead Sponsor: Trevena Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Disposition First Submitted: 2017-07-07
• Disposition First Submitted QC: 2017-07-07
• Disposition First Posted: 2017-07-11
• Results First Submitted: 2020-08-17
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-04
• Last Update Submitted: 2020-09-04
• Results First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 3 Oliceridine	Oliceridine	-
Placebo	Placebo	-
Morphine	Morphine	-
Treatment 1 Oliceridine	Oliceridine	-
Treatment 2 Oliceridine	Oliceridine	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.	48 hours

Secondary Outcome Measures

Name	Time	Method
Number of Respiratory Safety Events Compared to Morphine.	48 hours
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.	48 hours	Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure.
Number of Patients With Treatment-related Adverse Events.	48 hours
Duration of Respiratory Safety Events Compared to Morphine.	48 hours

Trial Locations

Locations (2)

Research Site; 🇺🇸 San Antonio, Texas, United States

Resarch Site; 🇺🇸 Salt Lake City, Utah, United States