NCT02504580

Pilot Herniorrhaphy Study for Postoperative Analgesia

A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy

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-011 is the initial formulation studied (HTX-011-19). 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

Interventions

Type	Name	Description
DRUG	HTX-011	HTX-011 (bupivacaine/meloxicam) by injection.
DRUG	Placebo	Saline placebo by injection.
DRUG	HTX-002	HTX-002, by injection or instillation (pooled).
DRUG	Bupivacaine HCI (Marcaine)	Bupivacaine HCI (Marcaine) by injection.
DRUG	HTX-011A	HTX-011A (bupivacaine/meloxicam) by injection.
DRUG	HTX-011B	HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
DRUG	HTX-009	HTX-009 by injection and instillation (combination).

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-03-01
• Completion: 2017-04-01
• First posted: 2015-07-22
• Last updated: 2026-03-02
• Results posted: 2023-10-04

Locations

3 sites across 1 country: United States