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Trial · NCT02820324

Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty

NCT02820324, Phase 3, Completed, Trevena Inc.; results first posted 2020-10-23

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty. Trials, record NCT02820324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02820324

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
NCT number
NCT02820324
Status
Completed
Phases
Phase 3
Enrollment
407 participants, actual
Lead sponsor
Trevena Inc.
Conditions
Acute Pain
Interventions
Oliceridine, Placebo, Morphine
First posted
2016-06-30
Last updated
2020-10-23
Results first posted
2020-10-23

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber 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.
SecondaryNumber of Respiratory Safety Events Compared to Morphine.24 hoursRespiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
SecondaryDuration of Respiratory Events Compared to Morphine.24 hoursRespiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
SecondaryOdds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.24 hoursOdds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure.
SecondaryNumber of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.24 hours

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.24 hoursThe analysis population reflects the number of patients treated with study medication.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Respiratory Safety Events Compared to Morphine.24 hoursThe analysis population reflects the number of patients treated with study medication.Respiratory Safety EventsNUMBER
SECONDARYDuration of Respiratory Events Compared to Morphine.24 hoursThe analysis population reflects the number of patients treated with study medication.hoursMEAN
SECONDARYOdds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.24 hours
The analysis population reflects the number of patients treated with study medication. The morphine and placebo Arms/Groups are not included, as this is a comparison of study medication against morphine.
odds ratioNUMBER
SECONDARYNumber of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.24 hoursParticipantsCOUNT_OF_PARTICIPANTS

Results by group23

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.Treatment 1 Oliceridine47Participants
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.Treatment 2 Oliceridine61Participants
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.Treatment 3 Oliceridine56Participants
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.Treatment 4 Placebo37Participants
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.Treatment 5 Morphine65Participants
Number of Respiratory Safety Events Compared to Morphine.Treatment 1 Oliceridine6Respiratory Safety Events
Number of Respiratory Safety Events Compared to Morphine.Treatment 2 Oliceridine17Respiratory Safety Events
Number of Respiratory Safety Events Compared to Morphine.Treatment 3 Oliceridine18Respiratory Safety Events
Number of Respiratory Safety Events Compared to Morphine.Treatment 4 Placebo5Respiratory Safety Events
Number of Respiratory Safety Events Compared to Morphine.Treatment 5 Morphine22Respiratory Safety Events

Participant flow20

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDTreatment 1 Oliceridine78
Overall StudySTARTEDTreatment 2 Oliceridine82
Overall StudySTARTEDTreatment 3 Oliceridine82
Overall StudySTARTEDTreatment 4 Placebo82
Overall StudySTARTEDTreatment 5 Morphine83
Overall StudyTreated With Study MedicationTreatment 1 Oliceridine77
Overall StudyTreated With Study MedicationTreatment 2 Oliceridine80
Overall StudyTreated With Study MedicationTreatment 3 Oliceridine80
Overall StudyTreated With Study MedicationTreatment 4 Placebo81
Overall StudyTreated With Study MedicationTreatment 5 Morphine83

Adverse events130

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNauseaGastrointestinal disordersTreatment 1 Oliceridine3477
otherNauseaGastrointestinal disordersTreatment 2 Oliceridine4980
otherNauseaGastrointestinal disordersTreatment 3 Oliceridine6080
otherNauseaGastrointestinal disordersTreatment 4 Placebo3881
otherNauseaGastrointestinal disordersTreatment 5 Morphine6183
otherVomitingGastrointestinal disordersTreatment 1 Oliceridine1877
otherVomitingGastrointestinal disordersTreatment 2 Oliceridine1780
otherVomitingGastrointestinal disordersTreatment 3 Oliceridine3480
otherVomitingGastrointestinal disordersTreatment 4 Placebo1181
otherVomitingGastrointestinal disordersTreatment 5 Morphine4483

Adverse event totals15

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityTreatment 1 Oliceridine077
Total, all-cause mortalityTreatment 2 Oliceridine080
Total, all-cause mortalityTreatment 3 Oliceridine080
Total, all-cause mortalityTreatment 4 Placebo081
Total, all-cause mortalityTreatment 5 Morphine083
Total, other adverse eventsTreatment 1 Oliceridine6977
Total, other adverse eventsTreatment 2 Oliceridine7480
Total, other adverse eventsTreatment 3 Oliceridine7680
Total, other adverse eventsTreatment 4 Placebo6581
Total, other adverse eventsTreatment 5 Morphine8083

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
31162798DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02820324

GET https://conductscience.org/api/trials/v1/NCT02820324/results?page=2