Clinical trial NCT02820324: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-30
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Respiratory Safety Events Compared to Morphine.
timeFrame: 24 hours
measure: Duration of Respiratory Events Compared to Morphine.
timeFrame: 24 hours
measure: Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.
timeFrame: 24 hours
measure: Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Pasadena
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: Maryland
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Trevena Inc.
name: Franck Skobieranda, MD
role: STUDY_DIRECTOR
References:
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.