Phase 3
N=407
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02820324 ↗Enrolled (actual)
407
Serious AEs
1.3%
Results posted
Oct 2020
Primary outcome: Primary: Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. — 47; 61; 56; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oliceridine (Drug); Placebo (Drug); Morphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trevena Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. |
47; 61; 56; 37; 65 | — |
| SECONDARY Number of Respiratory Safety Events Compared to Morphine. |
6; 17; 18; 5; 22 | — |
| SECONDARY Duration of Respiratory Events Compared to Morphine. |
2.27; 2.97; 3.43; 4.12; 3.17 | — |
| SECONDARY Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine. |
0.88; 2.11; 1.73 | — |
| SECONDARY Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine. |
52; 70; 70; 44; 76 | — |
Summary
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute pain after abdominoplasty.
Eligibility Criteria
Inclusion Criteria
- Has undergone abdominoplasty 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 procedure.
Exclusion Criteria
- ASA Physical Status Classification System classification of P3 or worse.
- Has surgical or post-surgical complications.
- Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Has previously participated in another TRV130 clinical study.
Data sourced from ClinicalTrials.gov (NCT02820324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.