At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 enrolled
Drug / intervention
HTX-011 +5 moredrug
Likely dose
HTX-011 300 mgfrom 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.
A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
In Brief
A Phase 2 clinical trial evaluating HTX-011, Luer lock applicator, and 4 other interventions for Postoperative Pain. Completed, enrolled 63 participants across 5 sites.
Detailed Summary
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartOct 2018
First PostedOct 2018
Primary CompletionNov 2018
Study CompletionDec 2018
TodayJul 2026
First PostedOct 4, 2018
Enrollment StartOct 1, 2018
Primary CompletionNov 20, 2018
Study CompletionDec 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.7 years ago
Interventions
HTX-011drug
HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.
Luer lock applicatordevice
Applicator for instillation.
Vial access devicedevice
Device for withdrawal of drug product.
Ibuprofendrug
Ibuprofen, 600 mg.
Acetaminophendrug
Acetaminophen, 1 g.
Ketorolacdrug
Intraoperative IV ketorolac.