240 Participants Needed

Cebranopadol for Acute Pain

(ALLEVIATE2 Trial)

Recruiting at 9 trial locations
AP
LM
JH
DF
EO
Overseen ByEmanuela Offidani
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you require analgesics for a condition unrelated to the bunion, you may not be eligible to participate.

What safety data is available for Cebranopadol?

Cebranopadol, also known as GRT-6005, PRK-101, and TRN-228, has been evaluated for safety in various studies. It has shown a better safety profile compared to typical opioids, with reduced side effects such as respiratory depression and abuse potential. Phase II clinical trials have demonstrated good tolerability in acute and chronic pain conditions. Preclinical studies in animal models have also indicated that cebranopadol does not disrupt motor coordination and respiration at doses within and exceeding the analgesic range. Additionally, a Phase 1 clinical trial in healthy volunteers assessed its respiratory effects, suggesting a ceiling effect in respiratory depression due to its action on the nociceptin/orphanin FQ receptor.12345

Is the drug Cebranopadol a promising treatment for acute pain?

Yes, Cebranopadol is a promising drug for treating acute pain. It is a new type of painkiller that works on two different pain pathways in the body, making it very effective. It has shown strong pain-relieving effects in various studies and has a better safety profile compared to traditional opioids like morphine. This means it can relieve pain effectively while having fewer side effects.12345

What data supports the idea that Cebranopadol for Acute Pain is an effective drug?

The available research shows that Cebranopadol is effective in treating pain. It has been tested in various animal models and has shown strong pain-relieving effects. Compared to morphine, a common painkiller, Cebranopadol has a better safety profile, meaning it causes fewer side effects. It also works for a longer time and delays the development of tolerance, which is when the body gets used to a drug and it becomes less effective. In clinical trials, Cebranopadol has shown good results in treating both acute and chronic pain, making it a promising option for pain management.12345

Who Is on the Research Team?

TM

Todd M Bertoch, MD

Principal Investigator

Cenexel JBR

Are You a Good Fit for This Trial?

This trial is for individuals experiencing acute pain following a bunionectomy, which is a surgical procedure to remove bunions. Participants should meet specific health criteria set by the study's guidelines.

Inclusion Criteria

Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires.
I am scheduled for a specific foot surgery to correct a bunion.

Exclusion Criteria

I have no complications from surgery that could affect study results.
History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs
My surgery and recovery followed all standard procedures.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Cebranopadol, placebo, or Oxycodone IR for 3 days to manage postoperative pain

3 days
Daily visits for medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cebranopadol
Trial Overview The study aims to test the effectiveness and safety of Cebranopadol in managing post-surgical pain compared with Oxycodone IR (a known painkiller) and a placebo (a substance with no therapeutic effect).
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CebranopadolExperimental Treatment2 Interventions
once daily for 3 days
Group II: Oxycodone IRActive Control1 Intervention
four times per day for 3 days
Group III: PlaceboPlacebo Group1 Intervention
three times per day 3 days (with cebranopadol); four times per day for 3 days (placebo arm)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tris Pharma, Inc.

Lead Sponsor

Trials
22
Recruited
4,800+

Published Research Related to This Trial

Cebranopadol, a new pain medication, showed significant analgesic effects in various mouse pain models, including acute and chronic pain, with efficacy comparable to morphine.
Unlike morphine, cebranopadol developed its pain-relieving effects more slowly and did not cause motor deficits, suggesting a better safety profile for treating conditions like diabetic neuropathy and cancer pain.
Evaluation of cebranopadol, a dually acting nociceptin/orphanin FQ and opioid receptor agonist in mouse models of acute, tonic, and chemotherapy-induced neuropathic pain.Sałat, K., Furgała, A., Sałat, R.[2023]
Cebranopadol, a new strong pain reliever, showed typical opioid-like effects, including respiratory depression, but with a significant advantage: it did not cause complete cessation of breathing (apnea) at the tested dose, unlike traditional opioids.
In a study involving 12 healthy male volunteers, cebranopadol demonstrated a half-life for respiratory depression of about 1.2 hours, suggesting a potentially safer profile for managing pain without severe respiratory risks.
Respiratory Effects of the Nociceptin/Orphanin FQ Peptide and Opioid Receptor Agonist, Cebranopadol, in Healthy Human Volunteers.Dahan, A., Boom, M., Sarton, E., et al.[2022]
Cebranopadol, a novel analgesic, shows promising pharmacokinetic properties with a long half-life of 62-96 hours and a time to reach maximum plasma concentration of 4-6 hours after oral administration, making it suitable for once-daily dosing.
The drug demonstrates dose proportionality across a wide range (200-1600 µg) and achieves steady state in about 2 weeks, indicating its potential effectiveness and stability for managing chronic pain.
Clinical Pharmacokinetic Characteristics of Cebranopadol, a Novel First-in-Class Analgesic.Kleideiter, E., Piana, C., Wang, S., et al.[2019]

Citations

Evaluation of cebranopadol, a dually acting nociceptin/orphanin FQ and opioid receptor agonist in mouse models of acute, tonic, and chemotherapy-induced neuropathic pain. [2023]
Respiratory Effects of the Nociceptin/Orphanin FQ Peptide and Opioid Receptor Agonist, Cebranopadol, in Healthy Human Volunteers. [2022]
Clinical Pharmacokinetic Characteristics of Cebranopadol, a Novel First-in-Class Analgesic. [2019]
Cebranopadol: a novel potent analgesic nociceptin/orphanin FQ peptide and opioid receptor agonist. [2023]
Cebranopadol: A Novel First-in-Class Potent Analgesic Acting via NOP and Opioid Receptors. [2023]
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