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A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
Full description
This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of the bupivacaine component. HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer was evaluated.
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Inclusion criteria
Subjects must meet all of the following criteria to be considered eligible to participate in the study:
Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol
Be American Society of Anesthesiology (ASA) physical Class I or II
Subjects 18 years of age or older
Have clinical laboratory values that are within normal limits (WNL); subjects with AST/ALT < 3 x ULN, and/or creatinine < 2 x ULN are acceptable.
Have a body mass index ≤ 30 kg/m2
Female subjects are eligible only if all of the following apply:
Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study
Does NOT have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
Must be able to understand study procedures and be willing to comply and give informed consent for the conduct of all study procedures, using an IRB approved consent
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from participating in the study:
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277 participants in 12 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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