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A Study of TRV130 for the Treatment of Pain After Abdominoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02335294
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Lotus Clinical Research, LLC
Information provided by (Responsible Party):
Trevena Inc.

Brief Summary:
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.

Condition or disease Intervention/treatment Phase
Pain Drug: TRV130 Drug: Morphine Drug: Placebo Phase 2

Detailed Description:
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty
Study Start Date : December 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRV130 Drug: TRV130
Rescue: Ibuprofen, oxycodone

Active Comparator: Morphine Drug: Morphine
Rescue: Ibuprofen, oxycodone
Other Name: Morphine sulphate

Placebo Comparator: Placebo Drug: Placebo
Rescue: Ibuprofen, oxycodone
Other Name: Dextrose 5% in water, D5W




Primary Outcome Measures :
  1. Time weighted average (TWA) change from baseline in pain score between TRV130 and placebo [ Time Frame: 24-hours ]
    Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 24 hours


Secondary Outcome Measures :
  1. Time weighted average (TWA) change from baseline in pain score between TRV130 and morphine [ Time Frame: 24-hours ]
    Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 24 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >=18 and <=65 years of age.
  • Plans to undergo an abdominoplasty procedure with no additional collateral procedures.
  • Is able to understand and comply with the procedures and study requirements, and 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): NCT02335294


Locations
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United States, California
Pasadena, California, United States, 91105
United States, Texas
Houston, Texas, United States, 77024
Sponsors and Collaborators
Trevena Inc.
Lotus Clinical Research, LLC

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Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02335294    
Other Study ID Numbers: CP130-2002
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: September 2017
Keywords provided by Trevena Inc.:
Pain
abdominoplasty
PCA
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents