NCT02762929

Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Detailed 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.

Conditions

• Postoperative Pain
• Bunions

Interventions

Type	Name	Description
DRUG	HTX-011A	HTX-011A (bupivacaine/meloxicam), via injection.
BIOLOGICAL	Saline Placebo	Saline placebo via injection.
DRUG	HTX-011B	HTX-011B (bupivacaine/meloxicam), via injection or instillation.
DRUG	HTX-002	HTX-002, via injection.
DRUG	Bupivacaine HCl	Bupivacaine HCI, via injection.
DRUG	HTX-009	HTX-009, via injection.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2016-05-05
• Last updated: 2026-02-23
• Results posted: 2023-10-04

Locations

5 sites across 1 country: United States