Cebranopadol for Acute Pain in Adults After Surgery or Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, open-label study to evaluate safety and efficacy of cebranopadol 400 µg in adults with acute pain from ambulatory surgery or musculoskeletal injuries. Participants must have a pain score of 4 or higher and meet other criteria, with follow-up to monitor outcomes and any adverse effects. The study will be conducted at three U.S. sites and involves continuous assessment of pain relief and safety signals. Status and results will inform whether cebranopadol could be an option for managing acute pain in this population.

Why it matters

Who can join: the full rules

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 it's running

• Adneuris Site 001115
  Phoenix, Arizona, United States Recruiting
• Adneuris Site 001118
  Riverside, California, United States Recruiting
• Adneuris Site 001119
  Longmont, Colorado, United States Recruiting
• Adneuris Site 001122
  Savannah, Georgia, United States Recruiting
• Adneuris Site 001123
  O'Fallon, Illinois, United States Recruiting
• Adneuris Site 001125
  Annapolis, Maryland, United States Recruiting

Study contacts

• Study coordinator: Study Director, Adneuris Therapeutics
• Email: clinicaltrials@trispharma.com
• Phone: 732-940-2800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cognitive Rehabilitation of Everyday Goals With GMT: How Different Ways of Delivery Work

  This study tests Goal Management Training to see if a Swedish version helps adults with acquired brain injury or chronic pain improve practical goal-directed thinking and daily functioning.

  Recruiting at 2 sites Karolinska Institutet · Luleå, Norrbotten County and 2 other locations · NCT07924774

• One-time Pain Reprocessing Therapy session for chronic pain at The Ottawa Hospital

  A single four-hour session of Pain Reprocessing Therapy is being tested to see if it can help adults with chronic pain feel better and have less pain.

  Recruiting Ottawa Hospital Research Institute · Ottawa, Ontario · NCT07919626

• Meaning-Based Psychotherapy for Adults with Chronic Pain

  This trial tests whether Meaning-Based Psychotherapy helps adults with chronic pain feel more purposeful, feel less depressed, and have a better quality of life compared with optimized usual care therapy.

  Recruiting Hospital Clinico Universitario San Cecilio · Granada, Granada · NCT07915440

• How chronic pain changes over time in kids with Duchenne Muscular Dystrophy

  This study is following children and teens with Duchenne Muscular Dystrophy for 6 months to see how their chronic pain changes and how it affects daily life.

  Recruiting Antalya Training and Research Hospital · Antalya, Antalya · NCT07892196

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

  This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.

  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.