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

NCT02820324 | Completed Phase 3 Results

• 1 other identifier: CP130-3002
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (4)

• Number of Respiratory Safety Events Compared to Morphine.

  24 hours

• Duration of Respiratory Events Compared to Morphine.

  24 hours

• Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.

  24 hours

• Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.

  24 hours

Study Arms (5)

Treatment 1 Oliceridine

EXPERIMENTAL

Drug: Oliceridine

Treatment 2 Oliceridine

EXPERIMENTAL

Drug: Oliceridine

Treatment 3 Oliceridine

EXPERIMENTAL

Drug: Oliceridine

Treatment 4 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Treatment 5 Morphine

ACTIVE COMPARATOR

Drug: Morphine

Interventions

Oliceridine DRUG

Treatment 1 Oliceridine; Treatment 2 Oliceridine; Treatment 3 Oliceridine

Placebo DRUG

Treatment 4 Placebo

Morphine DRUG

Treatment 5 Morphine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trevena Inc.: lead

Study Sites (5)

Research Site

Phoenix, Arizona, 85027, United States

Location

Research Site

Pasadena, California, 91105, United States

Location

Research Site

Pasadena, Maryland, 21122, United States

Location

Research Site

Houston, Texas, 77027, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 31162798 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Kelly Arscott
• Organization: Trevena, Inc.

karscott@trevena.com

6103548840

Study Officials

• Franck Skobieranda, MD

  Trevena Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 30, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 23, 2020
• Results First Posted: October 23, 2020

Record last verified: 2020-09

Locations

US (5)