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

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ClinicalTrials.gov Identifier: NCT02820324
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
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 pain after abdominoplasty.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Oliceridine Drug: Placebo Drug: Morphine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Treatment 1 Oliceridine Drug: Oliceridine
Experimental: Treatment 2 Oliceridine Drug: Oliceridine
Experimental: Treatment 3 Oliceridine Drug: Oliceridine
Placebo Comparator: Treatment 4 Placebo Drug: Placebo
Active Comparator: Treatment 5 Morphine Drug: Morphine



Primary Outcome Measures :
  1. Proportion of patients who respond to study medication at the 24-hr Numeric Pain Rating Scale (NRS) assessment compared to placebo. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Number of patients with hypoventilation events compared to morphine. [ Time Frame: 24 hours ]
  2. Duration of hypoventilation events compared to morphine. [ Time Frame: 24 hours ]
  3. Proportion of patients who respond to study medication at the 24-hr NRS assessment compared to morphine. [ Time Frame: 24 hours ]
  4. Number of patients with treatment-related adverse events compared to placebo and compared to morphine. [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820324


Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85027
United States, California
Research Site
Pasadena, California, United States, 91105
United States, Maryland
Research Site
Pasadena, Maryland, United States, 21122
United States, Texas
Research Site
Houston, Texas, United States, 77027
Research Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Trevena Inc.
Investigators
Study Director: Franck Skobieranda, MD Trevena Inc.

Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02820324     History of Changes
Other Study ID Numbers: CP130-3002
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents