Status:
COMPLETED
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Lead Sponsor:
Trevena Inc.
Conditions:
Acute Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT02815709
Start Date
May 1 2016
End Date
January 1 2017
Last Update
September 25 2020
Active Locations (7)
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1
Research Site
Phoenix, Arizona, United States, 85027
2
Research Site
Anaheim, California, United States, 92801
3
Research Site
Pasadena, California, United States, 91105
4
Research Site
Pasadena, Maryland, United States, 21122