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