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A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
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 each 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, and HTX-009, a meloxicam-only formulation in the same HTX-011 proprietary polymer, were evaluated.
Enrollment
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Inclusion criteria
Be male or female 18 years of age or older
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 until at least 1 week after the administration of study medication
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
Have the ability and be willing to comply with the study procedures.
Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form
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Interventional model
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430 participants in 11 patient groups
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Data sourced from clinicaltrials.gov
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