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Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy (APOLLO-1)

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: NCT02815709
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.

Study Description
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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 postoperative pain after bunionectomy.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 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 Bunionectomy
Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oliceridine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment 1 Oliceridine Drug: Oliceridine
Experimental: Treatment 2 Oliceridine Drug: Oliceridine
Experimental: Treatment 3 Oliceridine Drug: Oliceridine
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Morphine Drug: Morphine


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Number of Respiratory Safety Events Compared to Morphine. [ Time Frame: 48 hours ]
  2. Duration of Respiratory Safety Events Compared to Morphine. [ Time Frame: 48 hours ]
  3. Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. [ Time Frame: 48 hours ]
    Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure.

  4. Number of Patients With Treatment-related Adverse Events. [ Time Frame: 48 hours ]

Eligibility Criteria
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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 primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) 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.
Contacts and Locations
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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): NCT02815709


Locations
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United States, Arizona
Research Site
Phoenix, Arizona, United States, 85027
United States, California
Research Site
Anaheim, California, United States, 92801
Research Site
Pasadena, California, United States, 91105
United States, Maryland
Research Site
Pasadena, Maryland, United States, 21122
United States, Texas
Research Site
Austin, Texas, United States, 78229
Research Site
San Antonio, Texas, United States, 78229
United States, Utah
Resarch Site
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Trevena Inc.
Investigators
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Study Director: Franck Skobieranda, MD Trevena Inc.
More Information
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Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02815709    
Other Study ID Numbers: CP130-3001
First Posted: June 28, 2016    Key Record Dates
Results First Posted: September 25, 2020
Last Update Posted: September 25, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents