160 Participants NeededMy employer runs this trial

Cebranopadol for Pain

Recruiting at 14 trial locations
EQ
SD
Overseen ByStudy Director, Adneuris Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Adneuris Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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?

This trial tests the safety and effectiveness of a new treatment called cebranopadol for managing acute pain. Participants will take cebranopadol daily for up to 14 days or until their pain improves. It suits adults experiencing moderate to severe pain from recent surgery or a musculoskeletal condition (issues affecting muscles, bones, or joints) who can commit to following study guidelines. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new pain management option.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that may interfere with the study drug or pain assessments. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that cebranopadol is likely to be safe for humans?

Research has shown that cebranopadol is generally safe for people with pain. In previous studies, over 2,000 patients tried cebranopadol, and most did not experience major side effects. Specifically, small doses of 400 micrograms were used without problems. Another study found that cebranopadol was safe for patients with cancer-related pain, even at higher doses. These findings suggest that cebranopadol is well-tolerated, with few serious issues in managing different types of pain.12345

Why do researchers think this study treatment might be promising?

Cebranopadol is unique because it targets both the nociceptin and opioid receptors, offering a dual-action approach to pain relief. This sets it apart from traditional pain medications like NSAIDs and opioids that typically target only one type of receptor. Researchers are excited about Cebranopadol because it may provide effective pain relief with potentially reduced side effects and lower risk of addiction compared to conventional opioids. Additionally, its once-daily dosing could improve patient compliance and convenience.

What evidence suggests that cebranopadol might be an effective treatment for acute pain?

Research has shown that cebranopadol, which participants in this trial will receive, is a promising option for managing sudden pain. Previous studies found that cebranopadol effectively lowers pain levels, providing significant relief. It targets both opioid and non-opioid pathways, potentially offering pain relief with fewer side effects than traditional opioids. Early signs suggest cebranopadol could be effective for various types of pain, supporting its potential use in managing sudden pain. Overall, cebranopadol has demonstrated positive results in reducing pain, making it a strong candidate for further research in treating sudden pain.678910

Are You a Good Fit for This Trial?

This trial is for people experiencing acute pain, either from surgery or other causes. Participants should be adults who need pain relief and do not have conditions that would make the study unsafe for them.

Inclusion Criteria

I am between 18 and 75 years old.
Able to provide informed consent
I have a pain level of 4 or higher on a 0-10 scale.
See 2 more

Exclusion Criteria

Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study assessments
Known allergy or intolerance to cebranopadol or permitted rescue pain medications
Pregnant or breastfeeding
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Cebranopadol 400 µg once per day for up to 14 days or until pain resolves

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cebranopadol

Trial Overview

The study is testing cebranopadol, a new medication given at a dose of 400 micrograms, to see how safe and effective it is in treating short-term (acute) pain from various sources.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CebranopadolExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adneuris Therapeutics, Inc.

Lead Sponsor

Citations

Effectiveness

In medicine, effectiveness relates to how well a treatment works in practice, especially as shown opposed to efficacy,

The Effectiveness of Telemental Health: A 2013 Review - PMC

Telemental health is effective for diagnosis and assessment across many populations (adult, improving basic outcomes, and being well-accepted.4

3.

homvee.acf.gov

homvee.acf.gov/home

What is Home Visiting Evidence of Effectiveness? | Home ...

This video explains how HomVEE reviews research, rates model effectiveness, and determines which models meet criteria for evidence of effectiveness.

Evaluation Criteria

The OECD has defined six evaluation criteria – relevance, coherence, effectiveness, efficiency, impact and sustainability – and two principles for their use.

Effectiveness of Covid-19 Vaccines against the B.1.617.2 ...

Observational data from Qatar indicated modestly reduced effectiveness against symptomatic disease caused by this variant but high levels of ...

Tris Debuts Positive Data from Phase 3 Cebranopadol Trials

It has demonstrated positive clinical results in acute pain, chronic pain and diabetic neuropathic pain with a favorable safety profile. The ...

First Experience With Cancer-Related Pain for up to 26 ...

Cebranopadol was safe and well tolerated in patients with chronic moderate-to-severe pain related to cancer in the dose range tested (200–1000 μg once daily).

New Data Shows Cebranopadol's Potential in Acute Pain ...

Treatment with cebranopadol resulted in a significant reduction in pain intensity and a higher proportion of patients not requiring opioid ...

Cebranopadol as a Novel Promising Agent for the ... - PMC - NIH

The safety of cebranopadol was examined during in vitro and in vivo experiments. ... The above data indicate that cebranopadol may become an innovative analgesic.

Cebranopadol for Acute Pain (ALLEVIATE1 Trial)

Research has shown that cebranopadol is generally safe for people. In earlier studies, doses of 400 micrograms (a very small amount) were used without problems.