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Opioid Receptor Agonist
Oliceridine Arm for Acute Pain (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
RELIEVE Trial Summary
This trial tests a new drug to manage pain in burn injuries, which is complex and not well understood. The results could lead to better pain relief with fewer side effects.
Eligible Conditions
- Acute Pain
- Respiratory Depression
- Adverse Drug Reactions
- Burns
- Postoperative Nausea and Vomiting
RELIEVE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Analyze change in pain scores after initiation of oliceridine in patients with moderate or severe pain after acute burn injury
Secondary outcome measures
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 moreSide effects data
From 2017 Phase 3 trial • 418 Patients • NCT0281570956%
Nausea
39%
Vomiting
32%
Dizziness
25%
Headache
19%
Somnolence
15%
Pruritus
11%
Constipation
5%
Hypoxia
5%
Hyperhydrosis
5%
Sedation
5%
Dry Mouth
5%
Anxiety
4%
Oxygen Saturation Decreased
4%
Hot Flush
4%
Pruritus Generalized
1%
Chest Discomfort
1%
Muscle Twitching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment 2 Oliceridine
Treatment 3 Oliceridine
Placebo
Treatment 1 Oliceridine
Morphine
RELIEVE 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
Find a Location
Who is running the clinical trial?
University of TennesseeLead Sponsor
188 Previous Clinical Trials
141,610 Total Patients Enrolled
1 Trials studying Acute Pain
68 Patients Enrolled for Acute Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Oliceridine Arm
- Group 2: Historical control
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks come with using Oliceridine Arm for patients?
"Oliceridine Arm's safety score is 3, as it has advanced to Phase 4 trials and thus been approved for use."
Answered by AI
How many participants are being included in this research endeavor?
"Affirmative. Clinicaltrials.gov contains the information that this research endeavour, which was initially posted on April 1st 2023, is actively recruiting participants. 30 individuals need to be enrolled from 1 clinical centre."
Answered by AI
Are there still openings available to join this research endeavor?
"Affirmative. Information available on clinicaltrials.gov reveals that this research study is still enrolling patients; the trial was initially posted April 1st 2023, and most recently updated May 17th 2023. 30 participants are needed at a single medical facility."
Answered by AI
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