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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

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

Condition or disease Intervention/treatment Phase
Bunions Drug: HTX-011A Drug: Saline Drug: HTX-011B Drug: HTX-002 Drug: Bupivacaine Hydrochloride Injection Drug: HTX-009 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Summed pain intensity score will be assessed over 24 hours [ Time Frame: 0-24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762929


Locations
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United States, California
Anaheim, California, United States, 92801
Bakersfield, California, United States, 93311
United States, Maryland
Pasadena, Maryland, United States, 21122
United States, Texas
Houston, Texas, United States, 77027
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Heron Therapeutics

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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT02762929     History of Changes
Other Study ID Numbers: HTX-011-C2016-208
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Heron Therapeutics:
Analgesia
Bunionectomy

Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents