Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

NCT02762929 | Completed Phase 2 Results

• 1 other identifier: HTX-011-C2016-208
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 5

Brief Summary

A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Conditions

Postoperative Pain; Bunions

Keywords

Analgesia; Bunionectomy

Outcome Measures

Primary Outcomes (1)

• Mean Summed Pain Intensity (SPI) Score Over 24 Hours

  The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\*PI4+2\*PI6+2\*PI8+2\*PI10+2\*PI12+2\*PI14+4\*PI18+6\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).

  0-24 hours

Study Arms (11)

HTX-011A: 200 mg

EXPERIMENTAL

HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.

Drug: HTX-011A

HTX-011B: 30 mg

EXPERIMENTAL

HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection.

Drug: HTX-011B

HTX-011B : 60 mg

EXPERIMENTAL

HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation.

Drug: HTX-011B

HTX-011B: 120 mg

EXPERIMENTAL

HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation.

Drug: HTX-011B

HTX-011B: 200 mg

EXPERIMENTAL

HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection.

Drug: HTX-011B

Bupivacaine HCI

ACTIVE COMPARATOR

Bupivacaine HCI, 50 mg via injection.

Drug: Bupivacaine HCl

Saline Placebo

ACTIVE COMPARATOR

Saline placebo via injection.

Biological: Saline Placebo

HTX-002, 60 mg

EXPERIMENTAL

HTX- 002, 60 mg via injection.

Drug: HTX-002

HTX-002, 120 mg

EXPERIMENTAL

HTX-002, 120 mg via injection.

Drug: HTX-002

HTX-002, 200 mg

EXPERIMENTAL

HTX-002, 200 mg via injection.

Drug: HTX-002

HTX-009

EXPERIMENTAL

HTX-009, 3.6 mg via injection.

Drug: HTX-009

Interventions

HTX-011A DRUG

HTX-011A (bupivacaine/meloxicam), via injection.

HTX-011A: 200 mg

Saline Placebo BIOLOGICAL

Saline placebo via injection.

Saline Placebo

HTX-011B DRUG

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

HTX-011B : 60 mg; HTX-011B: 120 mg; HTX-011B: 200 mg; HTX-011B: 30 mg

HTX-002 DRUG

HTX-002, via injection.

HTX-002, 120 mg; HTX-002, 200 mg; HTX-002, 60 mg

Bupivacaine HCl DRUG

Bupivacaine HCI, via injection.

Bupivacaine HCI

HTX-009 DRUG

HTX-009, via injection.

HTX-009

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be male or female 18 years of age or older
• Female subjects are eligible only if all of the following apply:
• Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
• Not lactating
• Not planning to become pregnant while participating in the study
• Be surgically sterile; or be at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or be practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study
• Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication
• Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
• Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
• Have the ability and be willing to comply with the study procedures.
• Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form

You may not qualify if:

• Unwilling to sign informed consent or not willing or able to complete all study procedures
• Have a contraindication or be allergic to any medication to be used during the trial period
• Have clinically significant cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
• Have American Society of Anesthesiologists (ASA) Physical Status classification system category ≥4
• Have clinically significant renal or hepatic abnormalities: for example, AST or ALT \> 3x ULN, creatinine \> 2x ULN
• Have another pre-existing painful condition that may confound pain assessments
• Have another surgery planned within 30 days of procedure
• Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
• Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of scheduled surgery for this study
• Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
• Subjects who are receiving oxygen therapy at the time of screening
• Have participated in a clinical trial within 30 days of planned surgery

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (5)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Bakersfield, California, 93311, United States

Location

Unknown Facility

Pasadena, Maryland, 21122, United States

Location

Unknown Facility

Houston, Texas, 77027, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2019 Dec 16:rapm-2019-100714. doi: 10.1136/rapm-2019-100714. Online ahead of print.

  PMID: 31843865 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Bunion; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Tricia Mulford
• Organization: Heron Therapeutics, Inc.

tmulford@herontx.com

760-622-3709

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 5, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 23, 2026
• Results First Posted: October 4, 2023

Record last verified: 2026-02

Locations

US (5)