An Open-Label, Safety and Efficacy Study of Cebranopadol in Participants With Acute Pain With Surgical or Non-Surgical Origin
RecruitingPhase 3
An Open-Label, Single-Arm, Multiple-Dose, Phase 3 Safety and Efficacy Study of Cebranopadol in Participants With Moderate to Severe Acute Pain With Surgical or Non-Surgical Origin
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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.
About the study
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
What is being tested
- Cebranopadol 400 ug (drug)
Sponsor: Adneuris Therapeutics, Inc. · Participants: 160 · Started: 2026-09
Contact the study team
- Study Director, Adneuris Therapeutics · Phone: 732-940-2800
- Emilio Quetglas, MD · Phone: 732-940-2800
Official record on ClinicalTrials.gov — NCT07845071
Locations in the U.S.
| Arizona | Adneuris Site 001115, Phoenix (Not yet recruiting) |
| California | Adneuris Site 001118, Riverside (Not yet recruiting) |
| Colorado | Adneuris Site 001119, Longmont (Not yet recruiting) |
| Georgia | Adneuris Site 001122, Savannah (Not yet recruiting) |
| Illinois | Adneuris Site 001123, O'Fallon (Not yet recruiting) |
| Maryland | Adneuris Site 001125, Annapolis (Not yet recruiting) |
| New Jersey | Adneuris Site 001120, Oradell (Not yet recruiting) |
| Oklahoma | Adneuris Site 001124, Tulsa (Not yet recruiting) |
| Texas | Adneuris Site 001110, Bellaire (Not yet recruiting) Adneuris Site 001117, Forney (Not yet recruiting) Adneuris Site 001104, McAllen Adneuris Site 001116, Plano (Not yet recruiting) Adneuris Site 001111, San Antonio (Not yet recruiting) Adneuris Site 001121, San Antonio (Not yet recruiting) |
| Utah | Adneuris Site 001101, Salt Lake City (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.