NCT07845071PHASE3Recruiting
An Open-Label, Safety and Efficacy Study of Cebranopadol in Participants With Acute Pain With Surgical or Non-Surgical Origin
Adneuris Therapeutics, Inc.
Start Date
9/22/2026
Completion Date
2/1/2027
Summary
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
Eligibility Criteria
Age Range: 18 years to 75 years
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.
Interventions
DRUG
Cebranopadol 400 ug
Conditions
Pain
Locations
Adneuris Site 001115
Phoenix, Arizona 85053
United States
Adneuris Site 001118
Riverside, California 92504
United States
Adneuris Site 001119
Longmont, Colorado 80501
United States
Adneuris Site 001122
Savannah, Georgia 31406
United States
Adneuris Site 001123
O'Fallon, Illinois 62269
United States
Adneuris Site 001125
Annapolis, Maryland 21401
United States
Adneuris Site 001120
Oradell, New Jersey 07649
United States
Adneuris Site 001124
Tulsa, Oklahoma 74137
United States
Adneuris Site 001110
Bellaire, Texas 77401
United States
Adneuris Site 001117
Forney, Texas 75126
United States
Adneuris Site 001104
McAllen, Texas 78501
United States
Adneuris Site 001116
Plano, Texas 75093
United States
Adneuris Site 001111
San Antonio, Texas 78240
United States
Adneuris Site 001121
San Antonio, Texas 78240
United States
Adneuris Site 001101
Salt Lake City, Utah 84107
United States