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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02762929
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 5, 2016
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
Summed pain intensity score will be assessed over 24 hours [ Time Frame: 0-24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Official Title  ICMJE 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
Brief Summary A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bunions
Intervention  ICMJE
  • Drug: HTX-011A
  • Drug: Saline
  • Drug: HTX-011B
  • Drug: HTX-002
  • Drug: Bupivacaine Hydrochloride Injection
  • Drug: HTX-009
Study Arms  ICMJE
  • Experimental: Part A Cohort A
    200 mg of HTX-011A via closed wound infiltration
    Intervention: Drug: HTX-011A
  • Experimental: Part A Cohort B
    200 mg of HTX 011A via open wound infiltration
    Intervention: Drug: HTX-011A
  • Experimental: Part A Cohort C
    200 mg of HTX-011B via closed wound infiltration
    Intervention: Drug: HTX-011B
  • Experimental: Part A Cohort D
    200 mg of HTX 011B via open wound infiltration
    Intervention: Drug: HTX-011B
  • Active Comparator: Part A Cohort E
    50 mg 0.5% bupivacaine hydrochloride injection via a closed wound infiltration
    Intervention: Drug: Bupivacaine Hydrochloride Injection
  • Placebo Comparator: Part A Cohort F
    Saline Placebo via a closed wound infiltration
    Intervention: Drug: Saline
  • Experimental: Part B Cohort A
    200 mg HTX 002 via closed wound infiltration
    Intervention: Drug: HTX-002
  • Experimental: Part B Cohort B
    200 mg HTX 002 via open wound infiltration
    Intervention: Drug: HTX-002
  • Placebo Comparator: Part B Cohort C
    Saline placebo via a closed and open wound infiltration
    Intervention: Drug: Saline
  • Experimental: Part C Cohort A
    120 mg of HTX-011B via closed wound infiltration
    Intervention: Drug: HTX-011B
  • Experimental: Part C Cohort B
    120 mg of HTX-011B via open wound infiltration
    Intervention: Drug: HTX-011B
  • Experimental: Part C Cohort C
    120 mg of HTX-011B local administration via instillation
    Intervention: Drug: HTX-011B
  • Placebo Comparator: Part C Cohort D
    Saline placebo via open wound infiltration
    Intervention: Drug: Saline
  • Experimental: Part D Cohort A
    60 mg of HTX-011B via closed wound infiltration
    Intervention: Drug: HTX-011B
  • Experimental: Part D Cohort B
    60 mg of HTX-011B via open wound infiltration.
    Intervention: Drug: HTX-011B
  • Placebo Comparator: Part D Cohort C
    Saline placebo via open wound infiltration
    Intervention: Drug: Saline
  • Experimental: Part E Cohort A
    120 mg HTX 002 via closed wound infiltration
    Intervention: Drug: HTX-002
  • Experimental: Part E Cohort B
    120mg HTX 002 via open wound infiltration
    Intervention: Drug: HTX-002
  • Placebo Comparator: Part E Cohort C
    Saline placebo via closed and open wound infiltration
    Intervention: Drug: Saline
  • Experimental: Part F Cohort A
    HTX 009 via closed wound infiltration
    Intervention: Drug: HTX-009
  • Experimental: Part F Cohort B
    HTX 009 via open wound infiltration
    Intervention: Drug: HTX-009
  • Placebo Comparator: Part F Cohort C
    Saline placebo via closed and open wound infiltration
    Intervention: Drug: Saline
  • Experimental: Part G Cohort A
    30 mg of HTX 011B via closed wound infiltration
    Intervention: Drug: HTX-011B
  • Placebo Comparator: Part G Cohort B
    Saline placebo via closed wound infiltration
    Intervention: Drug: Saline
  • Experimental: Part H Cohort A
    120 mg of HTX-011-056
    Intervention: Drug: HTX-011B
  • Experimental: Part H Cohort B
    60 mg of HTX-011-056
    Intervention: Drug: HTX-011B
  • Placebo Comparator: Part H Cohort C
    4.1 mL of normal saline
    Intervention: Drug: Saline
Publications * 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. pii: rapm-2019-100714. doi: 10.1136/rapm-2019-100714. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2017)
430
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2016)
90
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02762929
Other Study ID Numbers  ICMJE HTX-011-C2016-208
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heron Therapeutics
Study Sponsor  ICMJE Heron Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heron Therapeutics
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP