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Oliceridine

Phase 3

Acute Pain | Small molecule | Pain |Trevena, Inc.|Last Updated: Oct 23, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment825

FDA Designations

No designations recorded

Clinical trial landscape

Oliceridine · 2 trials · 1 indication

Phase 3 2
NCT02815709Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After BunionectomyAcute Pain
COMPLETED418 Analytics
NCT02820324Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After AbdominoplastyAcute Pain
COMPLETED407 Analytics
PHASE3COMPLETED
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Acute PainUnlock trial analytics
PHASE3COMPLETED
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
Acute PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
48 hours
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
24 hours

The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.

Secondary Endpoints

Number of Respiratory Safety Events Compared to Morphine.
48 hours
Duration of Respiratory Safety Events Compared to Morphine.
48 hours
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment 1 OliceridineEXPERIMENTAL -
Treatment 2 OliceridineEXPERIMENTAL -
Treatment 3 OliceridineEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
MorphineACTIVE_COMPARATOR -
Treatment 4 PlaceboPLACEBO_COMPARATOR -
Treatment 5 MorphineACTIVE_COMPARATOR -

Interventions

NameTypeDescription
OliceridineDRUG -
PlaceboDRUG -
MorphineDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: * Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * Experiences a pain intensity rating of moderate to severe acute pain. * Able to provide written informed consent before any study proc...

Countries:United States
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Competitive Landscape -Acute Kidney Injury 14 trials (matched to "Acute Pain")

Frequently asked questions about Oliceridine

What is Oliceridine used for?

Oliceridine is an investigational small molecule being developed for the treatment of moderate to severe acute pain. It has been studied in Phase 3 clinical trials for acute pain following surgical procedures such as bunionectomy and abdominoplasty.

Who makes Oliceridine?

Oliceridine is being developed by Trevena, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol TRVN.

What phase is Oliceridine in?

Oliceridine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, but the drug remains under investigation.

What clinical trials is Oliceridine in?

Oliceridine has been studied in two completed Phase 3 clinical trials: NCT02815709, which enrolled 418 participants with acute pain after bunionectomy, and NCT02820324, which enrolled 407 participants with acute pain after abdominoplasty. Both trials were randomized, double-blind, and placebo-controlled.

Is Oliceridine the same as TRV130?

Yes, Oliceridine is also known as TRV130. The clinical trials for Oliceridine are titled 'Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain,' confirming that TRV130 is an alternative name for the drug.