Phase 3
Completed N=418
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
Source: ClinicalTrials.gov NCT03237481 ↗Enrolled (actual)
418
Serious AEs
1.0%
Results posted
Oct 2021
Primary outcomePrimary: Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo. — 269.39; 350.82 pain intensity score*hr — p== 0.0004
◆ Published Evidence
Emerging
9citations · ~2 / year
Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study.
Summary
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.
Linked Publications (2)
-
Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study.
-
HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo. |
269.39; 350.82 | = 0.0004 sig |
| SECONDARY Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl. |
269.39; 341.88 | < 0.0001 sig |
| SECONDARY Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo. |
10.85; 17.53 | = 0.0001 sig |
| SECONDARY Percetange of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. |
84; 69 | = 0.0486 sig |
| SECONDARY Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl. |
10.85; 14.51 | = 0.024 sig |
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.
Exclusion Criteria
- Had any prior inguinal hernia repair.
- Has a planned concurrent surgical procedure.
- Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- Has taken NSAIDs within 10 days prior to the scheduled surgery.
- Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
- Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
- Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
- Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
- Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.
- Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments.
- Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
- Has undergone 3 or more surgeries within 12 months.
- Has a body mass index (BMI) >39 kg/m2.
Data sourced from ClinicalTrials.gov (NCT03237481) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.