About this trial
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Cebranopadol 400 ug
DrugParticipants receive Cebranopadol 400 mcg once per day for 14 days or until pain resolves, whichever occurs first.
Treatment groups
Trial outcomes
Primary outcomes
Sum of pain intensity differences through 48 hours (SPID48)
Sum of pain intensity differences through 48 hours (SPID48), calculated from NPRS assessments collected following the first administration of cebranopadol.
Sponsors and contacts
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