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TRV130

Phase 3

Acute Pain | Small molecule | Pain |Trevena, Inc.|Last Updated: Sep 24, 2020

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,101
FDA Designations
No designations recorded
Clinical trial landscape

TRV130 · 5 trials · 4 indications

Phase 3 1Phase 2 2Phase 1 2
NCT02656875A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute PainAcute Pain
COMPLETED768 Analytics
PHASE3COMPLETED
A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain
Acute Pain
NCT02656875768
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Study Endpoints
Primary Endpoints
Number of Patients That Experienced a Treatment-emergent Adverse Event
From first dose through 3 days after last dose, approximately 4 days
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo
24-hours

Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.

Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo
48 hours

Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.

Part A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Prior to dose through 4 hours
Part B - Change from baseline in QTc
Prior to dose through 24 hours
Cold Pain Test
8 hours postdose
Secondary Endpoints
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine
24-hours
Part B - Pharmacodynamics - QTc
Prior to dose through 24 hours
Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Prior to dose through Follow-Up Visit
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TRV130EXPERIMENTALFor 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.
MorphineACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
TRV130 1 mgEXPERIMENTALTRV130 1 mg IV Q4H x 48 h
TRV130 2 mgEXPERIMENTALTRV130 2 mg IV Q4H x 48 h
TRV130 3 mgEXPERIMENTALTRV130 3 mg IV Q4H x 48 h
TRV130 4 mgEXPERIMENTALTRV130 4 mg IV Q4H x 48 h
Part AEXPERIMENTALFixed sequence, open label
Part BEXPERIMENTAL4 way cross over, double blind
TRV130 1.5 mgEXPERIMENTALTRV130 1.5 mg IV x 1 dose
TRV130 4.5 mgEXPERIMENTALTRV130 4.5 mg IV x 1 dose
Interventions
NameTypeDescription
TRV130DRUG -
MorphineDRUGRescue: Ibuprofen, oxycodone
PlaceboDRUGRescue: Ibuprofen, oxycodone
MoxifloxacinDRUG -
TRV130 1.5 mgDRUGTRV130 1.5 mg IV x 1 dose
TRV130 3 mgDRUGTRV130 3 mg IV x 1 dose
TRV130 4.5 mgDRUGTRV130 4.5 mg IV x 1 dose
Morphine 10 mgDRUGMorphine 10 mg IV x 1 dose
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 sig...

Countries:United States
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