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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 2017

Interventions

  • Drug: HTX-011A
  • Drug: Saline
  • Drug: HTX-011B
  • Drug: HTX-002
  • Drug: Bupivacaine Hydrochloride Injection
  • Drug: HTX-009

Arms, Groups and Cohorts

  • Experimental: Part A Cohort A
    • 200 mg of HTX-011A via closed wound infiltration
  • Experimental: Part A Cohort B
    • 200 mg of HTX 011A via open wound infiltration
  • Experimental: Part A Cohort C
    • 200 mg of HTX-011B via closed wound infiltration
  • Experimental: Part A Cohort D
    • 200 mg of HTX 011B via open wound infiltration
  • Active Comparator: Part A Cohort E
    • 50 mg 0.5% bupivacaine hydrochloride injection via a closed wound infiltration
  • Placebo Comparator: Part A Cohort F
    • Saline Placebo via a closed wound infiltration
  • Experimental: Part B Cohort A
    • 200 mg HTX 002 via closed wound infiltration
  • Experimental: Part B Cohort B
    • 200 mg HTX 002 via open wound infiltration
  • Placebo Comparator: Part B Cohort C
    • Saline placebo via a closed and open wound infiltration
  • Experimental: Part C Cohort A
    • 120 mg of HTX-011B via closed wound infiltration
  • Experimental: Part C Cohort B
    • 120 mg of HTX-011B via open wound infiltration
  • Experimental: Part C Cohort C
    • 120 mg of HTX-011B local administration via instillation
  • Placebo Comparator: Part C Cohort D
    • Saline placebo via open wound infiltration
  • Experimental: Part D Cohort A
    • 60 mg of HTX-011B via closed wound infiltration
  • Experimental: Part D Cohort B
    • 60 mg of HTX-011B via open wound infiltration.
  • Placebo Comparator: Part D Cohort C
    • Saline placebo via open wound infiltration
  • Experimental: Part E Cohort A
    • 120 mg HTX 002 via closed wound infiltration
  • Experimental: Part E Cohort B
    • 120mg HTX 002 via open wound infiltration
  • Placebo Comparator: Part E Cohort C
    • Saline placebo via closed and open wound infiltration
  • Experimental: Part F Cohort A
    • HTX 009 via closed wound infiltration
  • Experimental: Part F Cohort B
    • HTX 009 via open wound infiltration
  • Placebo Comparator: Part F Cohort C
    • Saline placebo via closed and open wound infiltration
  • Experimental: Part G Cohort A
    • 30 mg of HTX 011B via closed wound infiltration
  • Placebo Comparator: Part G Cohort B
    • Saline placebo via closed wound infiltration
  • Experimental: Part H Cohort A
    • 120 mg of HTX-011-056
  • Experimental: Part H Cohort B
    • 60 mg of HTX-011-056
  • Placebo Comparator: Part H Cohort C
    • 4.1 mL of normal saline

Clinical Trial Outcome Measures

Primary Measures

  • Summed pain intensity score will be assessed over 24 hours
    • Time Frame: 0-24 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heron Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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