Status and phase
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About
The purpose of this study is to show the effectiveness of COV155 compared to placebo in subjects with acute moderate to severe pain following bunionectomy surgery.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Voluntarily provide written informed consent
General good health
18 to 75 years of age
Scheduled for primary unilateral first metatarsal bunionectomy (with no collateral procedures)
Body mass index ≤33
Female subjects eligible if
Male subjects must be sterile (biologically or surgically) or use reliable birth control during the study until at least 1 week after the last dose of COV155
Classified as either Physical Status-1 (PS) or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
Willing to complete pain assessments and clinic visits.
Additional inclusion criterion for randomization into the Double-Blind Phase: Subjects must experience postoperative pain intensity score ≥5 on a 0 to 10 Numerical Pain Rating Score (NPRS) more than 1 hour, and less than 9 hours after discontinuing the nerve block, and at least 30 minutes after the last ice pack has been removed (if used).
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
406 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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