A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy (NCT06423703) | Clinical Trial Compass
CompletedPhase 3
A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy
United States240 participantsStarted 2024-07-18
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria Before Surgery:
* Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned.
* Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires.
Key Exclusion Criteria Before Surgery:
* Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject.
* Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator.
* Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase.
* History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs.
Immediate Postoperative Exclusion Criteria:
* Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
* Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safet…
What they're measuring
1
Pain NRS area under the curve: cebranopadol vs. placebo