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A Study of TRV130 for the Treatment of Pain After Bunionectomy

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: NCT02100748
Recruitment Status : Completed
First Posted : April 1, 2014
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 IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

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

Detailed Description:
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. Additional objectives are to evaluate the efficacy and safety of TRV130 compared to morphine. Pharmacokinetics of TRV130 and morphine will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Multiple-dose, Adaptive, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain After Bunionectomy
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRV130 1 mg
TRV130 1 mg IV Q4H x 48 h
Drug: TRV130
TRV130 1 - 4 mg will be administered every 4 hours

Experimental: TRV130 2 mg
TRV130 2 mg IV Q4H x 48 h
Drug: TRV130
TRV130 1 - 4 mg will be administered every 4 hours

Experimental: TRV130 3 mg
TRV130 3 mg IV Q4H x 48 h
Drug: TRV130
TRV130 1 - 4 mg will be administered every 4 hours

Experimental: TRV130 4 mg
TRV130 4 mg IV Q4H x 48 h
Drug: TRV130
TRV130 1 - 4 mg will be administered every 4 hours

Active Comparator: Morphine
Morphine 4 mg IV Q4H x 48 h
Drug: Morphine
Morphine 4 mg will be administered every 4 hours
Other Name: Morphine sulphate

Placebo Comparator: Placebo
Placebo (D5W) IV Q4H x 48 h
Drug: Placebo
Placebo will be administered every 4 hours
Other Names:
  • Dextrose 5% in water
  • D5W




Primary Outcome Measures :
  1. Reduction of Pain Intensity following Bunionectomy [ Time Frame: 48 hours ]
    Pain intensity will be evaluated by an 11-point numeric rating scale administered intermittently over 48 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥ 4 on an 11 point NRS
  • 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): NCT02100748


Locations
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United States, Arizona
Premier Research
Phoenix, Arizona, United States, 85027
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Texas
Premier Research
Austin, Texas, United States, 78705
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Trevena Inc.
Investigators
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Study Director: Franck Skobieranda, MD Trevena Inc.

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Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02100748    
Other Study ID Numbers: CP130-2001
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Keywords provided by Trevena Inc.:
moderate to severe acute pain
bunionectomy
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents