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

September 13, 2023 updated by: Heron Therapeutics

A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of each component. HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer, and HTX-009, a meloxicam-only formulation in the same HTX-011 proprietary polymer, were evaluated.

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
      • Bakersfield, California, United States, 93311
    • Maryland
      • Pasadena, Maryland, United States, 21122
    • Texas
      • Houston, Texas, United States, 77027
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be male or female 18 years of age or older

  2. Female subjects are eligible only if all of the following apply:

    1. Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
    2. Not lactating
    3. Not planning to become pregnant while participating in the study
    4. 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
  3. 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
  4. Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
  5. Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
  6. Have the ability and be willing to comply with the study procedures.
  7. Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form

Exclusion Criteria:

  1. Unwilling to sign informed consent or not willing or able to complete all study procedures
  2. Have a contraindication or be allergic to any medication to be used during the trial period
  3. Have clinically significant cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
  4. Have American Society of Anesthesiologists (ASA) Physical Status classification system category ≥4
  5. Have clinically significant renal or hepatic abnormalities: for example, AST or ALT > 3x ULN, creatinine > 2x ULN
  6. Have another pre-existing painful condition that may confound pain assessments
  7. Have another surgery planned within 30 days of procedure
  8. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
  9. 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
  10. Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
  11. Subjects who are receiving oxygen therapy at the time of screening
  12. Have participated in a clinical trial within 30 days of planned surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HTX-011A: 200 mg
HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.
Drug: HTX-011A
HTX-011A (bupivacaine/meloxicam), via injection.
Experimental: HTX-011B: 30 mg
HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection.
Drug: HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
Experimental: HTX-011B : 60 mg
HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation.
Drug: HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
Experimental: HTX-011B: 120 mg
HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation.
Drug: HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
Experimental: HTX-011B: 200 mg
HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection.
Drug: HTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
Active Comparator: Bupivacaine HCI
Bupivacaine HCI, 50 mg via injection.
Drug: Bupivacaine HCl
Bupivacaine HCI, via injection.
Active Comparator: Saline Placebo
Saline placebo via injection.
Biological: Saline Placebo
Saline placebo via injection.
Experimental: HTX-002, 60 mg
HTX- 002, 60 mg via injection.
Drug: HTX-002
HTX-002, via injection.
Experimental: HTX-002, 120 mg
HTX-002, 120 mg via injection.
Drug: HTX-002
HTX-002, via injection.
Experimental: HTX-002, 200 mg
HTX-002, 200 mg via injection.
Drug: HTX-002
HTX-002, via injection.
Experimental: HTX-009
HTX-009, 3.6 mg via injection.
Drug: HTX-009
HTX-009, via injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Summed Pain Intensity (SPI) Score Over 24 Hours
Time Frame: 0-24 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heron Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimated)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTX-011-C2016-208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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