Cebranopadol for Acute Pain
(ALLEVIATE2 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Cebranopadol, placebo, or Oxycodone IR for 3 days to manage postoperative pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cebranopadol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tris Pharma, Inc.
Lead Sponsor