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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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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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