NCT02689258

Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery

A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery

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 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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	HTX-011B	HTX- 011B (bupivacaine/meloxicam) via injection
DRUG	Placebo	Saline placebo via injection
DRUG	HTX-011A	HTX- 011A (bupivacaine/meloxicam) via injection
DRUG	HTX-002	HTX-002 via combination
DRUG	Bupivicaine HCl	Bupivacaine HCl via injection

Timeline

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

Locations

8 sites across 1 country: United States