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

T

Trevena

Status and phase

Completed
Phase 3

Conditions

Acute Pain

Treatments

Drug: Oliceridine
Drug: Morphine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02815709
CP130-3001

Details and patient eligibility

About

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.

Enrollment

418 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

418 participants in 5 patient groups, including a placebo group

Treatment 1 Oliceridine
Experimental group
Treatment:
Drug: Oliceridine
Treatment 2 Oliceridine
Experimental group
Treatment:
Drug: Oliceridine
Treatment 3 Oliceridine
Experimental group
Treatment:
Drug: Oliceridine
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Morphine
Active Comparator group
Treatment:
Drug: Morphine

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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