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

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

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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