Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South… (NCT05509868) | Clinical Trial Compass
CompletedPhase 3
Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
South Korea182 participantsStarted 2022-07-25
Plain-language summary
The primary objective is to evaluate the analgesic efficacy of PBK\_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.
Who can participate
Age range19 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.
Inclusion Criteria:
* Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation
* Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.
Exclusion Criteria:
* Participated in another oliceridine clinical study.
* Received any investigational drug, device or therapy within 35 days before surgery.
* Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study.
* American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.