NCT03718039

Brief Summary

This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_2 postoperative-pain

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

June 26, 2023

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

October 22, 2018

Results QC Date

June 11, 2021

Last Update Submit

February 10, 2026

Conditions

Postoperative Pain

Keywords

bunionbunionectomybunion surgerypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores

    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), sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).

    72 hours

Secondary Outcomes (4)

  • Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) Through 72 Hours

    72 hours

  • Percentage of Subjects Receiving no Opioid Rescue

    72 hours

  • Percentage of Subjects Receiving no Opioid Rescue

    Day 7 and Day 28

  • Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores

    72 hours

Study Arms (3)

Treatment Group 1: HTX-011

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.

Drug: HTX-011Device: Luer Lock applicatorDevice: Vial access device

Treatment Group 2: HTX-011 + Aprepitant

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.

Drug: HTX-011Device: Luer Lock applicatorDevice: Vial access deviceDrug: aprepitant

Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.

Drug: HTX-011Device: Luer Lock applicatorDevice: Vial access device

Interventions

HTX-011DRUG

HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.

Treatment Group 1: HTX-011Treatment Group 2: HTX-011 + AprepitantTreatment Group 3: HTX-011 + Non-Opioid MMA Regimen
Luer Lock applicatorDEVICE

Applicator for instillation.

Treatment Group 1: HTX-011Treatment Group 2: HTX-011 + AprepitantTreatment Group 3: HTX-011 + Non-Opioid MMA Regimen
Vial access deviceDEVICE

Device for withdrawal of drug product.

Treatment Group 1: HTX-011Treatment Group 2: HTX-011 + AprepitantTreatment Group 3: HTX-011 + Non-Opioid MMA Regimen
aprepitantDRUG

Aprepitant, three single doses of aprepitant will be administered orally.

Treatment Group 2: HTX-011 + Aprepitant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. For cohort 2, acceptable contraceptives excludes hormonal contraceptives.

You may not qualify if:

  • Has had a contralateral foot bunionectomy in the past 3 months prior to the scheduled surgery.
  • Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot).
  • Has a 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 long-acting opioids within 3 days prior to the scheduled surgery.
  • Has taken any opioids within 24 hours prior to the scheduled surgery.
  • Has been administered bupivacaine within 5 days prior to the scheduled surgery.
  • For Cohort 2 only, has been administered aprepitant or another NK1 receptor antagonist within 5 days prior to the scheduled surgery.
  • Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
  • Has initiated treatment with study 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).
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pain, PostoperativeBunion

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

October 24, 2018

Primary Completion

January 31, 2019

Study Completion

March 11, 2019

Last Updated

March 2, 2026

Results First Posted

June 26, 2023

Record last verified: 2026-02

Locations

US(1)