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Recruiting NCT07845071

An Open-Label, Safety and Efficacy Study of Cebranopadol in Participants With Acute Pain With Surgical or Non-Surgical Origin

Conditions: Pain

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 160
Sponsor: Adneuris Therapeutics, Inc.

Location: Adneuris Site 001115 Phoenix Arizona

Summary

The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07845071). StuddyBuddy aggregates publicly available trial information.