Trial Outcomes & Findings for A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain (NCT NCT02656875)

NCT ID: NCT02656875

Last Updated: 2020-09-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 768 participants
• Primary outcome timeframe: From first dose through 3 days after last dose, approximately 4 days
• Results posted on: 2020-09-24

Participant Flow

Participant milestones

Measure	TRV130 For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval.
Overall Study STARTED	768
Overall Study COMPLETED	698
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain

Baseline characteristics by cohort

Measure	TRV130 n=768 Participants For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval. TRV130
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	521 Participants n=5 Participants
Age, Categorical >=65 years	247 Participants n=5 Participants
Age, Continuous	54.1 years STANDARD_DEVIATION 16.08 • n=5 Participants
Sex: Female, Male Female	498 Participants n=5 Participants
Sex: Female, Male Male	270 Participants n=5 Participants
Race/Ethnicity, Customized White	596 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	137 Participants n=5 Participants
Race/Ethnicity, Customized Asian	13 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	14 Participants n=5 Participants
Race/Ethnicity, Customized Missing Race	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	61 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	704 Participants n=5 Participants
Race/Ethnicity, Customized Missing Ethnicity	3 Participants n=5 Participants
Region of Enrollment United States	768 participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose through 3 days after last dose, approximately 4 days

Outcome measures

Measure	TRV130 n=768 Participants For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval.
Number of Patients That Experienced a Treatment-emergent Adverse Event	490 Participants

Adverse Events

TRV130

Serious events: 26 serious events

Other events: 403 other events

Deaths: 0 deaths

Serious adverse events

Measure	TRV130 n=768 participants at risk For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval.
Cardiac disorders Atrial Fibrillation	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Gastrointestinal disorders Flatulence	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Gastrointestinal disorders Intra-Abdominal Hemorrhage	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Gastrointestinal disorders Nausea	0.26% 2/768 • Number of events 2 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Gastrointestinal disorders Small Intestinal Obstruction	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Hepatobiliary disorders Hepatic Failure	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Infections and infestations Abdominal Abscess	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Infections and infestations Clostridium Difficile Colitis	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Infections and infestations Graft Infection	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Infections and infestations Pelvic Abscess	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Infections and infestations Postoperative Wound Infection	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Infections and infestations Sepsis	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Injury, poisoning and procedural complications Anemia Postoperative	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Injury, poisoning and procedural complications Postprocedural Hematoma	0.26% 2/768 • Number of events 2 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Injury, poisoning and procedural complications Postprocedural Hemorrhage	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Injury, poisoning and procedural complications Postoperative Ileus	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Injury, poisoning and procedural complications Wound Dehiscence	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Investigations Blood Creatinine Increased	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Metabolism and nutrition disorders Hyponatremia	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Nervous system disorders Syncope	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Psychiatric disorders Mental Status Changes	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Renal and urinary disorders Acute Kidney Injury	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Renal and urinary disorders Renal Failure	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Reproductive system and breast disorders Breast Hematoma	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Respiratory, thoracic and mediastinal disorders Respiratory Depression	0.13% 1/768 • Number of events 1 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.

Other adverse events

Measure	TRV130 n=768 participants at risk For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval.
Gastrointestinal disorders Nausea	31.1% 239/768 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Gastrointestinal disorders Constipation	10.9% 84/768 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.
Gastrointestinal disorders Vomiting	10.4% 80/768 • Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Adverse events were collected from time of first dose through the follow-up visit, which occurred up to 3 days after last dose (approximately 4 days total). Serious Adverse Events were collected from informed consent through 7 days following last dose.

Additional Information

Kelly Arscott

Trevena, Inc.

Phone: 6103548840

Email: karscott@trevena.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER