Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
Recruiting in Palo Alto (17 mi)
+23 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Heron Therapeutics
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing unilateral open inguinal herniorrhaphy.
Eligibility Criteria
Inclusion Criteria
Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
Has an American Society of Anesthesiologists Physical Status of I, II, or III.
Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Treatment Details
Interventions
- Bupivacaine HCl (Local Anesthetic)
- HTX-011 (Local Anesthetic)
- Luer-lock applicator (Procedure)
- Saline placebo (Placebo)
- Vial access device (Device)
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Treatment Group 1: HTX-011Experimental Treatment3 Interventions
HTX 011 (bupivacaine/meloxicam)
Group II: Treatment Group 2: Bupivacaine HCIActive Control1 Intervention
Bupivacaine HCl
Group III: Treatment Group 3: Saline PlaceboPlacebo Group2 Interventions
Saline placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Midwest Clinical ResearchDayton, OH
Hermann Drive Surgical HospitalHouston, TX
University of MiamiMiami, FL
eStudySiteLas Vegas, NV
More Trial Locations
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Who Is Running the Clinical Trial?
Heron TherapeuticsLead Sponsor