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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oliceridine
Placebo
Morphine
Sponsored by
Trevena Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Has undergone abdominoplasty 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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Treatment 1 Oliceridine

Treatment 2 Oliceridine

Treatment 3 Oliceridine

Treatment 4 Placebo

Treatment 5 Morphine

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.

Secondary Outcome Measures

Number of Respiratory Safety Events Compared to Morphine.
Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Duration of Respiratory Events Compared to Morphine.
Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.
Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure.
Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.

Full Information

First Posted
June 9, 2016
Last Updated
September 30, 2020
Sponsor
Trevena Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02820324
Brief Title
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
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 Abdominoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevena Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 pain after abdominoplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1 Oliceridine
Arm Type
Experimental
Arm Title
Treatment 2 Oliceridine
Arm Type
Experimental
Arm Title
Treatment 3 Oliceridine
Arm Type
Experimental
Arm Title
Treatment 4 Placebo
Arm Type
Placebo Comparator
Arm Title
Treatment 5 Morphine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Oliceridine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Morphine
Primary Outcome Measure Information:
Title
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
Description
The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Respiratory Safety Events Compared to Morphine.
Description
Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Time Frame
24 hours
Title
Duration of Respiratory Events Compared to Morphine.
Description
Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Time Frame
24 hours
Title
Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.
Description
Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure.
Time Frame
24 hours
Title
Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Has undergone abdominoplasty 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Skobieranda, MD
Organizational Affiliation
Trevena Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Research Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Research Site
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31162798
Citation
Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.
Results Reference
derived

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

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