Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

Postoperative Pain Clinical Trial

Official title:

A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295721
• Other study ID #: HTX-011-301
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: September 2021
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 bunionectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: March 13, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional 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:

• Has had a contralateral foot bunionectomy in the past 3 months.
• Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot).
• 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 any NSAIDs within at least 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.
• As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
• Has uncontrolled anxiety, psychiatric, or neurological disorder.
• 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, benzodiazepine for anxiety 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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• HTX-011
HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation
• Saline Placebo
Saline placebo by instillation
• Bupivacaine HCl
Bupivacaine HCl without epinephrine, 50 mg by injection

Device:
• Luer-lock applicator
Applicator for instillation
• Vial access device
Device for withdrawal of drug product

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Optimal Research , LLC	Austin	Texas
United States	Trovare Clinical Research, Inc.	Bakersfield	California
United States	Hermann Drive Surgical Hospital	Houston	Texas
United States	Westside Surgical Hospital	Houston	Texas
United States	Alliance Research Centers	Laguna Hills	California
United States	Futuro Clinical Trials, LLC	McAllen	Texas
United States	Orthopaedic Specialists of North America, PLLC	Mesa	Arizona
United States	Springhill Medical Center	Mobile	Alabama
United States	EPIC Medical Research, LLC	Murray	Utah
United States	Chesapeake Research Group, LLC	Pasadena	Maryland
United States	Arizona Research Center	Phoenix	Arizona
United States	Plano Surgical Hospital	Plano	Texas
United States	Jean Brown Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX-011 Compared With Saline Placebo.	Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).	72 hours
Secondary	Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.	Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A) seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).	72 hours
Secondary	Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.		72 hours
Secondary	Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.		72 hours
Secondary	Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.		72 hours