NCT07845071 · Adneuris Therapeutics, Inc.
An Open-Label, Safety and Efficacy Study of Cebranopadol in Participants With Acute Pain With Surgical or Non-Surgical Origin
What this study is about
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
View original scientific description
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
Interventions
DRUG
Cebranopadol 400 ug
Participants receive Cebranopadol 400 mcg once per day for 14 days or until pain resolves, whichever occurs first.
Primary outcome measures
Sum of pain intensity differences through 48 hours (SPID48)
Time frame: From 0 through 48 hours
Sum of pain intensity differences through 48 hours (SPID48), calculated from NPRS assessments collected following the first administration of cebranopadol.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults 18 to 75 years of age.
- Able to provide informed consent.
- Experiencing moderate to severe acute pain related to: 1) An ambulatory surgical procedure expected to cause pain lasting at least 72 hours, or 2) A traumatic or non-traumatic musculoskeletal condition.
- Have a pain score of at least 4 on a 0 to 10 pain rating scale before starting study treatment.
- Willing and able to comply with study requirements
Exclusion criteria
- Chronic pain condition that requires ongoing pain medication.
- Significant medical or psychiatric condition that could affect participation or study results.
- History of substance use disorder or misuse of alcohol or drugs.
- Current use of medications that may interfere with the study drug or pain assessments.
- Known allergy or intolerance to cebranopadol or permitted rescue pain medications.
- Pregnant or breastfeeding.
- Participation in another clinical trial or receipt of an investigational drug within the protocol-defined period before study entry.
- Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study assessments.
Where
- Phoenix, Arizona
- Riverside, California
- Longmont, Colorado
- Savannah, Georgia
- O'Fallon, Illinois
- Annapolis, Maryland
- Oradell, New Jersey
- Tulsa, Oklahoma
- Bellaire, Texas
- Forney, Texas
- McAllen, Texas
- Plano, Texas
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 28, 2026 · Source of record for eligibility and locations