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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Number of Respiratory Safety Events Compared to Morphine. | 24 hours | Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status. |
| Secondary | Duration of Respiratory Events Compared to Morphine. | 24 hours | Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status. |
| Secondary | Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine. | 24 hours | Odds 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. |
| Secondary | Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine. | 24 hours |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | 24 hours | The analysis population reflects the number of patients treated with study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Respiratory Safety Events Compared to Morphine. | 24 hours | The analysis population reflects the number of patients treated with study medication. | Respiratory Safety Events | NUMBER |
| SECONDARY | Duration of Respiratory Events Compared to Morphine. | 24 hours | The analysis population reflects the number of patients treated with study medication. | hours | MEAN |
| SECONDARY | Odds 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 ratio | NUMBER |
| SECONDARY | Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine. | 24 hours | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | Treatment 1 Oliceridine | 47 | Participants | ||
| Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | Treatment 2 Oliceridine | 61 | Participants | ||
| Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | Treatment 3 Oliceridine | 56 | Participants | ||
| Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | Treatment 4 Placebo | 37 | Participants | ||
| Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | Treatment 5 Morphine | 65 | Participants | ||
| Number of Respiratory Safety Events Compared to Morphine. | Treatment 1 Oliceridine | 6 | Respiratory Safety Events | ||
| Number of Respiratory Safety Events Compared to Morphine. | Treatment 2 Oliceridine | 17 | Respiratory Safety Events | ||
| Number of Respiratory Safety Events Compared to Morphine. | Treatment 3 Oliceridine | 18 | Respiratory Safety Events | ||
| Number of Respiratory Safety Events Compared to Morphine. | Treatment 4 Placebo | 5 | Respiratory Safety Events | ||
| Number of Respiratory Safety Events Compared to Morphine. | Treatment 5 Morphine | 22 | Respiratory Safety Events |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment 1 Oliceridine | 78 | |
| Overall Study | STARTED | Treatment 2 Oliceridine | 82 | |
| Overall Study | STARTED | Treatment 3 Oliceridine | 82 | |
| Overall Study | STARTED | Treatment 4 Placebo | 82 | |
| Overall Study | STARTED | Treatment 5 Morphine | 83 | |
| Overall Study | Treated With Study Medication | Treatment 1 Oliceridine | 77 | |
| Overall Study | Treated With Study Medication | Treatment 2 Oliceridine | 80 | |
| Overall Study | Treated With Study Medication | Treatment 3 Oliceridine | 80 | |
| Overall Study | Treated With Study Medication | Treatment 4 Placebo | 81 | |
| Overall Study | Treated With Study Medication | Treatment 5 Morphine | 83 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Treatment 1 Oliceridine | 34 | 77 | |
| other | Nausea | Gastrointestinal disorders | Treatment 2 Oliceridine | 49 | 80 | |
| other | Nausea | Gastrointestinal disorders | Treatment 3 Oliceridine | 60 | 80 | |
| other | Nausea | Gastrointestinal disorders | Treatment 4 Placebo | 38 | 81 | |
| other | Nausea | Gastrointestinal disorders | Treatment 5 Morphine | 61 | 83 | |
| other | Vomiting | Gastrointestinal disorders | Treatment 1 Oliceridine | 18 | 77 | |
| other | Vomiting | Gastrointestinal disorders | Treatment 2 Oliceridine | 17 | 80 | |
| other | Vomiting | Gastrointestinal disorders | Treatment 3 Oliceridine | 34 | 80 | |
| other | Vomiting | Gastrointestinal disorders | Treatment 4 Placebo | 11 | 81 | |
| other | Vomiting | Gastrointestinal disorders | Treatment 5 Morphine | 44 | 83 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment 1 Oliceridine | 0 | 77 |
| Total, all-cause mortality | Treatment 2 Oliceridine | 0 | 80 |
| Total, all-cause mortality | Treatment 3 Oliceridine | 0 | 80 |
| Total, all-cause mortality | Treatment 4 Placebo | 0 | 81 |
| Total, all-cause mortality | Treatment 5 Morphine | 0 | 83 |
| Total, other adverse events | Treatment 1 Oliceridine | 69 | 77 |
| Total, other adverse events | Treatment 2 Oliceridine | 74 | 80 |
| Total, other adverse events | Treatment 3 Oliceridine | 76 | 80 |
| Total, other adverse events | Treatment 4 Placebo | 65 | 81 |
| Total, other adverse events | Treatment 5 Morphine | 80 | 83 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31162798 | DERIVED |
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.
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