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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

Sponsor: Adneuris Therapeutics, Inc. · Participants: 160 · Started: 2026-09

Contact the study team

Official record on ClinicalTrials.gov — NCT07845071

Locations in the U.S.

ArizonaAdneuris Site 001115, Phoenix (Not yet recruiting)
CaliforniaAdneuris Site 001118, Riverside (Not yet recruiting)
ColoradoAdneuris Site 001119, Longmont (Not yet recruiting)
GeorgiaAdneuris Site 001122, Savannah (Not yet recruiting)
IllinoisAdneuris Site 001123, O'Fallon (Not yet recruiting)
MarylandAdneuris Site 001125, Annapolis (Not yet recruiting)
New JerseyAdneuris Site 001120, Oradell (Not yet recruiting)
OklahomaAdneuris Site 001124, Tulsa (Not yet recruiting)
TexasAdneuris 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)
UtahAdneuris 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.