CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 463 enrolled
Drug / intervention
HTX-011 +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02504580
NCT02504580Phase 2Completed
CompareCT.gov

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

Heron Therapeutics·interventional·Posted Jul 22, 2015·Updated Mar 2, 2026

In Brief

A Phase 2 clinical trial evaluating HTX-011, Placebo, and 5 other interventions for Postoperative Pain. Completed, enrolled 463 participants across 3 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 22, 2015
Enrollment StartJul 1, 2015
Primary CompletionMar 1, 2017
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.9 years ago

Interventions

HTX-011drug

HTX-011 (bupivacaine/meloxicam) by injection.

Placebodrug

Saline placebo by injection.

HTX-002drug

HTX-002, by injection or instillation (pooled).

Bupivacaine HCI (Marcaine)drug

Bupivacaine HCI (Marcaine) by injection.

HTX-011Adrug

HTX-011A (bupivacaine/meloxicam) by injection.

HTX-011Bdrug

HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.

HTX-009drug

HTX-009 by injection and instillation (combination).