APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the µ-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy
| Autor: | David A. Burt, Neil Singla, David G. Soergel, Emily Cook, Eugene R. Viscusi, Franck Skobieranda |
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| Rok vydání: | 2019 |
| Předmět: |
orthopedic surgery
business.industry medicine.drug_class Analgesic Oliceridine analgesia clinical trial Placebo Loading dose patient controlled chemistry.chemical_compound Anesthesiology and Pain Medicine Tolerability chemistry Opioid Anesthesia Morphine medicine postoperative Antiemetic Journal of Pain Research business Original Research medicine.drug |
| Zdroj: | Journal of Pain Research |
| ISSN: | 1178-7090 |
| Popis: | Eugene R Viscusi,1 Franck Skobieranda,2 David G Soergel,2 Emily Cook,2 David A Burt,2 Neil Singla3 1Department of Anesthesiology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA; 2Trevena Inc., Chesterbrook, PA, USA; 3Lotus Clinical Research, LLC, Pasadena, CA, USA Purpose: Oliceridine is a novel G protein-biased µ-opioid receptor agonist designed to provide intravenous (IV) analgesia with a lower risk of opioid-related adverse events (ORAEs) than conventional opioids. Patients and methods: APOLLO-1 (NCT02815709) was a phase III, double-blind, randomized trial in patients with moderate-to-severe pain following bunionectomy. Patients received a loading dose of either placebo, oliceridine (1.5mg), or morphine (4mg), followed by demand doses via patient-controlled analgesia (0.1, 0.35, or 0.5mg oliceridine, 1mg morphine, or placebo). The primary endpoint compared the proportion of treatment responders through 48 hours for oliceridine regimens and placebo. Secondary outcomes included a composite measure of respiratory safety burden (RSB, representing the cumulative duration of respiratory safety events) and the proportion of treatment responders vs morphine. Results: Effective analgesia was observed for all oliceridine regimens, with responder rates of 50%, 62%, and 65.8% in the 0.1 mg, 0.35 mg, and 0.5 mg regimens, respectively(allP |
| Databáze: | OpenAIRE |
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