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Pilot Herniorrhaphy Study for Postoperative Analgesia

NCT02504580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2026-03-02

Study results available
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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

Conditions

  • Postoperative Pain

Interventions

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).

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504580 on ClinicalTrials.gov