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Opioid Receptor Agonist

Oliceridine Arm for Postoperative Nausea and Vomiting (RELIEVE Trial)

Phase 4

Waitlist Available

Research Sponsored by University of Tennessee

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 3-4 hours as standard of care allows or study medication continued, up to 7 days

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing Oliceridine, a new pain medication, on patients with acute burn injuries. It aims to provide effective pain relief with fewer side effects compared to traditional opioids. The medication targets specific pathways to reduce pain while minimizing risks like respiratory issues.

Eligible Conditions

Slow Breathing
Postoperative Nausea and Vomiting
Acute Pain
Burns
Adverse Drug Reactions

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 3-4 hours as standard of care allows or study medication continued, up to 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 3-4 hours as standard of care allows or study medication continued, up to 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 3-4 hours as standard of care allows or study medication continued, up to 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analyze change in pain scores after initiation of oliceridine in patients with moderate or severe pain after acute burn injury

Secondary study objectives

Characterize adverse events associated with administration of oliceridine in patients with acute burn injury

Establish a burn injury-specific half maximal effective concentration

Establish a burn injury-specific half-life

+1 more

Side effects data

From 2017 Phase 3 trial • 418 Patients • NCT02815709

56%

Nausea

39%

Vomiting

32%

Dizziness

25%

Headache

19%

Somnolence

15%

Pruritus

11%

Constipation

Sedation

Dry Mouth

Anxiety

Hypoxia

Hyperhydrosis

Hot Flush

Oxygen Saturation Decreased

Pruritus Generalized

Muscle Twitching

Chest Discomfort

100%

80%

60%

40%

20%

Study treatment Arm

Treatment 2 Oliceridine

Placebo

Morphine

Treatment 1 Oliceridine

Treatment 3 Oliceridine

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Oliceridine ArmExperimental Treatment1 Intervention

Initially, patients will receive oliceridine 1-3 mg IVP every 1-3 hours as needed for moderate or severe pain (NRS ≥ 4) with 1-3 mg every 1-3 hours for breakthrough pain. NRS will be assessed every 3-4 hours routinely. Rescue doses will be allowed per clinical discretion as oliceridine 1-3 mg every hour. Doses will be titrated according to patient response and clinical discretion. In settings where rapid analgesia is needed, such as the operating room, post-anesthesia care unit, emergency room, or hydrotherapy, oliceridine will be administered in 0.5-2 mg doses every 5 minutes as needed for moderate or severe pain, according to anesthesiologist or treating physician's discretion. For the purposes of the study oliceridine will not exceed 7 days of administration and patients will be transitioned from intravenous opioids to oral therapy and de-escalated from opioids, as soon as the team deems appropriate.

Group II: Historical controlActive Control1 Intervention

Retrospective, observational, historical control arm matched by age, TBSA, number of surgeries, and opioid and illicit drug use histories

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oliceridine

2023

Completed Phase 4

~860

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