ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The μ-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy
Sergio D Bergese,1 Marek Brzezinski,2 Gregory B Hammer,3 Timothy L Beard,4 Peter H Pan,5 Sharon E Mace,6 Richard D Berkowitz,7 Kristina Cochrane,8 Linda Wase,8 Harold S Minkowitz,9 Ashraf S Habib10 1School of Medicine, Stony Brook University, Stony Brook, NY, USA; 2School of Medicine, University of California San Francisco, VA Medical Center, San Francisco, CA, USA; 3Stanford University School of Medicine, Stanford, CA, USA; 4Clinical Research, Summit Medical Group/Bend Memorial Clinic, Bend, OR, USA; 5Wake Forest School of Medicine, Winston-Salem, NC, USA; 6Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, Cleveland, OH, USA; 7Phoenix Clinical Research, Tamarac, FL, USA; 8Trevena, Inc., Chesterbrook, PA, USA; 9HD Research Corporation, Houston, TX, USA; 10Duke University Medical Center, Durham, NC, USACorrespondence: Sergio D BergeseSchool of Medicine, Stony Brook University, Health Sciences Center, Level 4, Room 060, Stony Brook, NY 11794, USATel +1 631-444-2979Fax +1-631-444-2907Email Sergio.Bergesestonybrookmedicine.eduBackground: Pain management with conventional opioids can be challenging due to dose-limiting adverse events (AEs), some of which may be related to the simultaneous activation of β-arrestin (a signaling pathway associated with opioid-related AEs) and G-protein pathways. The investigational analgesic oliceridine is a G-protein-selective agonist at the μ-opioid receptor with less recruitment of β-arrestin. The objective of this phase 3, open-label, multi-center study was to evaluate the safety and tolerability, of IV oliceridine for moderate to severe acute pain in a broad, real-world patient population, including postoperative surgical patients and non-surgical patients with painful medical conditions.Methods: Adult patients with a score ≥4 on 11-point NRS for pain intensity received IV oliceridine either by bolus or PCA; multimodal analgesia was permitted. Safety was assessed using AE reports, study discontinuations, clinical laboratory and vital sign measures.Results: A total of 768 patients received oliceridine. The mean age (SD) was 54.1 (16.1) years, with 32% ≥65 years of age. Most patients were female (65%) and Caucasian (78%). Surgical patients comprised the majority of the study population (94%), most common being orthopedic (30%), colorectal (15%) or gynecologic (15%) procedures. Multimodal analgesia was administered to 84% of patients. Oliceridine provided a rapid reduction in NRS pain score by 2.2 +- 2.3 at 30 mins from a score of 6.3 +- 2.1 (at baseline) which was maintained to the end of treatment. No deaths or significant cardiorespiratory events were reported. The incidence of AEs leading to early discontinuation and serious AEs were 2% and 3%, respectively. Nausea (31%), constipation (11%), and vomiting (10%) were the most common AEs. AEs were mostly of mild (37%) or moderate (25%) severity and considered possibly or probably related to oliceridine in 33% of patients.Conclusion: Oliceridine IV for the management of moderate to severe acute pain was generally safe and well tolerated in the patients studied.ClinicalTrials.gov identifier: NCT02656875.Keywords: acute pain, analgesia, patient-controlled, clinical trial.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2019 |
|---|---|
| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2019 |
|---|---|
| Enthalten in: |
Journal of Pain Research - (2019), Seite 3113-3126 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Bergese SD [VerfasserIn] |
|---|
| Links: |
doaj.org [kostenfrei] |
|---|
| Themen: |
Acute pain |
|---|
| Förderinstitution / Projekttitel: |
|
|---|
| PPN (Katalog-ID): |
DOAJ074246143 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | DOAJ074246143 | ||
| 003 | DE-627 | ||
| 005 | 20230501184424.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 230228s2019 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)DOAJ074246143 | ||
| 035 | |a (DE-599)DOAJ8075d2bcaefd4067923a62068dd436af | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 050 | 0 | |a R5-920 | |
| 100 | 0 | |a Bergese SD |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The μ-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a Sergio D Bergese,1 Marek Brzezinski,2 Gregory B Hammer,3 Timothy L Beard,4 Peter H Pan,5 Sharon E Mace,6 Richard D Berkowitz,7 Kristina Cochrane,8 Linda Wase,8 Harold S Minkowitz,9 Ashraf S Habib10 1School of Medicine, Stony Brook University, Stony Brook, NY, USA; 2School of Medicine, University of California San Francisco, VA Medical Center, San Francisco, CA, USA; 3Stanford University School of Medicine, Stanford, CA, USA; 4Clinical Research, Summit Medical Group/Bend Memorial Clinic, Bend, OR, USA; 5Wake Forest School of Medicine, Winston-Salem, NC, USA; 6Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, Cleveland, OH, USA; 7Phoenix Clinical Research, Tamarac, FL, USA; 8Trevena, Inc., Chesterbrook, PA, USA; 9HD Research Corporation, Houston, TX, USA; 10Duke University Medical Center, Durham, NC, USACorrespondence: Sergio D BergeseSchool of Medicine, Stony Brook University, Health Sciences Center, Level 4, Room 060, Stony Brook, NY 11794, USATel +1 631-444-2979Fax +1-631-444-2907Email Sergio.Bergesestonybrookmedicine.eduBackground: Pain management with conventional opioids can be challenging due to dose-limiting adverse events (AEs), some of which may be related to the simultaneous activation of β-arrestin (a signaling pathway associated with opioid-related AEs) and G-protein pathways. The investigational analgesic oliceridine is a G-protein-selective agonist at the μ-opioid receptor with less recruitment of β-arrestin. The objective of this phase 3, open-label, multi-center study was to evaluate the safety and tolerability, of IV oliceridine for moderate to severe acute pain in a broad, real-world patient population, including postoperative surgical patients and non-surgical patients with painful medical conditions.Methods: Adult patients with a score ≥4 on 11-point NRS for pain intensity received IV oliceridine either by bolus or PCA; multimodal analgesia was permitted. Safety was assessed using AE reports, study discontinuations, clinical laboratory and vital sign measures.Results: A total of 768 patients received oliceridine. The mean age (SD) was 54.1 (16.1) years, with 32% ≥65 years of age. Most patients were female (65%) and Caucasian (78%). Surgical patients comprised the majority of the study population (94%), most common being orthopedic (30%), colorectal (15%) or gynecologic (15%) procedures. Multimodal analgesia was administered to 84% of patients. Oliceridine provided a rapid reduction in NRS pain score by 2.2 +- 2.3 at 30 mins from a score of 6.3 +- 2.1 (at baseline) which was maintained to the end of treatment. No deaths or significant cardiorespiratory events were reported. The incidence of AEs leading to early discontinuation and serious AEs were 2% and 3%, respectively. Nausea (31%), constipation (11%), and vomiting (10%) were the most common AEs. AEs were mostly of mild (37%) or moderate (25%) severity and considered possibly or probably related to oliceridine in 33% of patients.Conclusion: Oliceridine IV for the management of moderate to severe acute pain was generally safe and well tolerated in the patients studied.ClinicalTrials.gov identifier: NCT02656875.Keywords: acute pain, analgesia, patient-controlled, clinical trial | ||
| 650 | 4 | |a acute pain | |
| 650 | 4 | |a analgesia | |
| 650 | 4 | |a patient-controlled | |
| 650 | 4 | |a clinical trial | |
| 653 | 0 | |a Medicine (General) | |
| 700 | 0 | |a Brzezinski M |e verfasserin |4 aut | |
| 700 | 0 | |a Hammer GB |e verfasserin |4 aut | |
| 700 | 0 | |a Beard TL |e verfasserin |4 aut | |
| 700 | 0 | |a Pan PH |e verfasserin |4 aut | |
| 700 | 0 | |a Mace SE |e verfasserin |4 aut | |
| 700 | 0 | |a Berkowitz RD |e verfasserin |4 aut | |
| 700 | 0 | |a Cochrane K |e verfasserin |4 aut | |
| 700 | 0 | |a Wase L |e verfasserin |4 aut | |
| 700 | 0 | |a Minkowitz HS |e verfasserin |4 aut | |
| 700 | 0 | |a Habib AS |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i In |t Journal of Pain Research |d Dove Medical Press, 2009 |g (2019), Seite 3113-3126 |w (DE-627)DOAJ000111899 |x 11787090 |7 nnns |
| 773 | 1 | 8 | |g year:2019 |g pages:3113-3126 |
| 856 | 4 | 0 | |u https://doaj.org/article/8075d2bcaefd4067923a62068dd436af |z kostenfrei |
| 856 | 4 | 0 | |u https://www.dovepress.com/athena-a-phase-3-open-label-study-of-the-safety-and-effectiveness-of-o-peer-reviewed-article-JPR |z kostenfrei |
| 856 | 4 | 2 | |u https://doaj.org/toc/1178-7090 |y Journal toc |z kostenfrei |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_DOAJ | ||
| 912 | |a SSG-OLC-PHA | ||
| 951 | |a AR | ||
| 952 | |j 2019 |h 3113-3126 | ||