Clinical trial NCT02656875: A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain
Official title: A Phase 3, Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain for Which Parenteral Opioid Therapy is Warranted
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined by the investigator, for a duration not to exceed 14 days.

Detailed description: The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. Eligible patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA administration, or both, as determined by the investigator, for a duration not to exceed 14 days. The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. A follow-up assessment will take place 2-3 days after the completion of the treatment phase.

Eligibility criteria: Inclusion Criteria include:

* Moderate to severe acute pain for which parenteral opioid therapy is warranted
* Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.

Exclusion Criteria include:

* Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that would confound the interpretation of safety, tolerability, or efficacy data in the study.
* Hemodynamic instability or respiratory insufficiency.
* Advanced cancer in palliative or end-of-life care.
* Another current painful condition (other than acute pain for which parenteral opioid therapy is warranted) that would confound the interpretation of safety, tolerability, or efficacy data in the study.
* Clinically significant, immune-mediated hypersensitivity reaction to opioids.

Primary outcomes:
measure: Number of Patients That Experienced a Treatment-emergent Adverse Event
timeFrame: From first dose through 3 days after last dose, approximately 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Recruiting
state: Alabama
city: Pasadena
country: United States
facility: Recruiting
state: California
city: Miami
country: United States
facility: Recruiting
state: Florida
city: Shreveport
country: United States
facility: Recruiting
state: Louisiana
city: Jackson
country: United States
facility: Recruiting
state: Mississippi
city: Staten Island
country: United States
state: New York
city: State College
country: United States
facility: Recruiting
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Murray
country: United States
facility: Recruiting
state: Utah
Study officials:
affiliation: Trevena Inc.
name: Franck Skobieranda, MD
role: STUDY_CHAIR
References:
citation: Bergese SD, Brzezinski M, Hammer GB, Beard TL, Pan PH, Mace SE, Berkowitz RD, Cochrane K, Wase L, Minkowitz HS, Habib AS. ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The micro-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy. J Pain Res. 2019 Nov 14;12:3113-3126. doi: 10.2147/JPR.S217563. eCollection 2019.