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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.

June 9, 2016
June 30, 2016
July 11, 2017
May 2016
December 2016   (Final data collection date for primary outcome measure)
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 ]
Proportion of patients who respond to study medication at the 48-hr Numeric Pain Rating Scale (NRS) assessment compared to placebo. [ Time Frame: 48 hours ]
Complete list of historical versions of study NCT02820324 on ClinicalTrials.gov Archive Site
  • Number of patients with hypoventilation events compared to morphine. [ Time Frame: 24 hours ]
  • Duration of hypoventilation events compared to morphine. [ Time Frame: 24 hours ]
  • Proportion of patients who respond to study medication at the 24-hr NRS assessment compared to morphine. [ Time Frame: 24 hours ]
  • Number of patients with treatment-related adverse events compared to placebo and compared to morphine. [ Time Frame: 24 hours ]
  • Number of patients with hypoventilation events compared to morphine. [ Time Frame: 48 hours ]
  • Duration of hypoventilation events compared to morphine. [ Time Frame: 48 hours ]
  • Proportion of patients who respond to study medication at the 48-hr NRS assessment compared to morphine. [ Time Frame: 48 hours ]
  • Number of patients with treatment-related adverse events compared to placebo and compared to morphine. [ Time Frame: 48 hours ]
Not Provided
Not Provided
 
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Pain
  • Drug: Oliceridine
  • Drug: Placebo
  • Drug: Morphine
  • Experimental: Treatment 1 Oliceridine
    Intervention: Drug: Oliceridine
  • Experimental: Treatment 2 Oliceridine
    Intervention: Drug: Oliceridine
  • Experimental: Treatment 3 Oliceridine
    Intervention: Drug: Oliceridine
  • Placebo Comparator: Treatment 4 Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Treatment 5 Morphine
    Intervention: Drug: Morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
401
Not Provided
January 2017
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02820324
CP130-3002
No
Not Provided
Not Provided
Trevena Inc.
Trevena Inc.
Not Provided
Study Director: Franck Skobieranda, MD Trevena Inc.
Trevena Inc.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP